Lung LLC

Date:

December 02, 2011

Title:

Biostatistics Specialist, XenoLung

Job Type:

Full-Time Position

Job Category:

Clinical Operations

Location:

Silver Spring, MD

Experience Required:

Minimum five years experience as lead member of a biostatistics group within the pharmaceutical or health care industry

Education Level:

Ph.d or equivalent degree in Biostatistics

Role Purpose/Position Overview

The individual in this position will be responsible for gathering and analyzing data that will yield meaningful conclusions associated with end-stage lung disease by applying their knowledge of statistics, science and mathematics to important questions in health care and public health.

Key Accountabilities/Responsibilities

Responsibilities include:

• Utilize statistical software to translate data into useful information; use standard statistical procedures and terms to help researchers pinpoint which results are significant/ inconclusive.
• Analyze imperfect data set to help researchers glean useful conclusions from it.
• Ability to design new ways to gather and analyze data when presented with new challenges.
• perform sample/size/power calculations and stratification/randomization of studies; statistical
• Perform sample/size/power calculations and stratification/randomization of studies; statistical programming, data analysis, and report writing.
• Develop data collection plans and coordinate various surveillance systems; coordinates and carries out data collection, processing, and analysis.
• Provide consultation on design of data processing systems, specifying the needed output, the required input and the methods of validation and quality control.
• Responsible for ensuring the statistical validity and epidemiologic applicability of study activities by solving problems occurring in the data collection process.
• Recommend and carry out effective statistical methodology and strategies necessary for the creation, completion, and analysis of epidemiology or research projects and supervises the planning and designing of analytical procedures by others.
• Develop sampling methods, determines samples size and draws samples of populations to be studied.
• Recommend analytical design for a broad range of data. And the most appropriate statistical procedures for evaluation of outcome of studies.
• Use a wide variety of statistical procedures including but not limited to categorical data analysis, exploratory and graphical methods, analysis of variance, correlation analysis, multiple linear regression, time series analysis, logistic regression, survival analysis, spatial analysis, and non-parametric methods.
• Support the preparation of peer-reviewed publications, serve as primary and/or co-author on publications.
• Serve as a statistical reviewer and editor for other manuscripts produced by the professional staff.
• Provides technical leadership, consultation, advice on statistical analysis, methods and techniques for epidemiologic or research studies. 

Requirements

Minimum five years of experience including but not limited to the following:

• Lead member of a biostatistics group within the pharmaceutical or health care industry
• Expert knowledge of study design and analytic methods, coding systems commonly used in health care delivery.
• Experience working with a wide variety of data structures, coding schemes and data sources.
• Skilled in various statistical procedures and in application of advanced analytical techniques, data manipulation and linkage of large datasets.
• Analysis of large data using SAS/SPSS and SEER*Stat.
• Utilize statistical principles, data analysis, and computing
• Experience with ClinTrial, InForm, and Medidata for data collection; also expert knowledge of computer hardware and software systems appropriate for manipulation of large datasets.
• Experienced in data analysis; prior use of SharePoint, Oracle, SAP RPM, and/ or NetPoint a plus.
• Ability to operate Apple and/ or PC; Advanced Microsoft Office Suite (2007 and 2010) skills: Word, Excel, Outlook, PowerPoint, Project required, as well as Adobe Acrobat, Visio and excellent data entry skills.  

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

December 02, 2011

Title:

Budget Management Specialist, XenoLung

Job Type:

Full-Time Position

Job Category:

Research & Development

Location:

Silver Spring, MD

Experience Required:

Ten years experience developing and managing operating budgets in excess of $10M per year.

Education Level:

MBA degree and Certified Public Accountant (CPA) license required

Role Purpose/Position Overview

The individual in this position will coordinate the preparation, monitoring, analysis, evaluation and recommendation of departmental budgets.

Key Accountabilities/Responsibilities

Responsibilities include:

• Oversees the “Budget Reporting and Analysis Supporting System (BRASS)” used to monitor department budgets, creating budgets, producing reports and project expenditures.
• If necessary, assists and trains specified users on financial software by adding users to computer systems, testing software, conducting education programs, and working with users to solve problems.
• Performs administrative duties by gathering data and reports, processing applications, planning and publishing fiscal year end schedules, building data files and spreadsheets, assisting with special projects.
• Develops methods and procedures for budget analysis and control and assists in the development of management policies and guidelines.
• Manages, coordinates, and determines priorities of work load, monitoring levels of resources, establishing time lines, recommending changes and suggestions, writing, reviewing and editing reports prepared by staff, and approving completed projects and reports.
• Responds to information requests and conducts research.
• Ensures unit work conforms to company, local, state, and federal governmental regulations, and other applicable rules and requirements.
• Plans, organizes and performs budget analysis, reporting, projections and expenditure level recommendations.
• Plans and schedules work activities and establish goals and priorities; reviews work progress and implements appropriate corrective actions to resolve problems and deficiencies.
• Assists department/s in budget preparation and tracking, audits and administrative duties as applicable; coordinates preparation of the budget manual.
• Responds to inquiries and provides information concerning budgets. 

Requirements

• Ten years experience developing and managing operating budgets in excess of $10M per year.
• Extensive knowledge of budgetary, accounting and reporting systems, Generally Accepted Accounting Principles (GAAP) and Governmental Accounting Standards Board (GASB) required.
• Experience operating budgetary, accounting and reporting systems; specifically Concur, SAP, SAS Financial Management, FML.
• Ability to operate Apple and/ or PC; Advanced Microsoft Office Suite (2007 and 2010) skills: Word, Excel, Outlook, PowerPoint, Project required, as well as Adobe Acrobat, Visio and excellent data entry skills
• Strong verbal and written communication skills, excellent troubleshooting and relationship-building skills.
• Ability to work effectively in a team environment with both local and remote team members, and as individual.
• Ability to deal with various skill/ technical levels of business acumen.
• Strong decision-making and judgment skills, as well as excellent research, analytical and problem-solving skills.
• Ability to focus on goals and anticipate/ reduce risk.

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

December 02, 2011

Title:

CBER Specialist, XenoLung

Job Type:

Full-Time Position

Job Category:

Regulatory

Location:

Silver Spring, MD

Experience Required:

Minimum ten years previous experience within the FDA and/or working in an FDA-regulated company

Education Level:

Bachelor’s Degree in Science or related field; Master's degree highly preferred

Role Purpose/Position Overview

This position will be primarily responsible for obtaining all necessary regulatory approvals for United Theraepeutics’ xenograft program concerning the Center for Biologics Evaluation and Research Organization (CBER) within the FDA. 

Key Accountabilities/Responsibilities

Responsibilities include:

• Oversee the regulation process for products requiring governmental approval, including filing necessary applications and handling all government interactions.
• Perform quality audits/ write improvement plans, reliability engineering, fault analysis and troubleshooting, corrective action tracking and quality management training.
• Manage complaint handling, reporting, vigilance reporting, field actions, and label control.
• Development of clinical investigation plans, Case Report Forms and conduct of monitoring in compliance with GCP’s and ISO, CE FDA, etc. regulations.
• Ensure the proper processes, policies and procedures are in place to obtain necessary regulatory approvals and maintain regulatory compliance.
• Monitor external regulatory developments, identify risks, and communicate potential issues to senior management.
• Assure all regulatory submissions are accurate and submitted in a timely manner and determine if regulatory submissions are required or if a memo-to-file is adequate.
• Assure all marketing, sales and other materials (e.g. labels) and practices are in conformance with regulatory requirements.
• Development and execution of clinical investigation training for investigators, site personnel, and internal Xeno Lung clinical applications support personnel in compliance with good clinical practices.
• Assure compliance with all related regulations governing conduct of clinical investigations including financial disclosure.
• Administration of ongoing relationships with Institutional Review Boards, Ethics Committees, and country competent authorities including ongoing reporting obligations for continuing studies, FDA clinical trials registry requirements, and other applicable regulations.
• Assist in the planning and budgeting for clinical investigations supportive to product development objectives.
• Coordinate inspection of the organization and contract facilities, and develops procedures to ensure regulatory compliance.
• Generate reports, utilizing statistics, as appropriate, to evaluate trends and to aid management in the identification and resolution of issues and overall quality improvement effort.  Recommend KPI’s to measure compliance with quality standards and effectiveness of corrective actions across all functions.
• Assure control and proper disposition of nonconforming products and corrective actions.
• Maintain Corrective & Preventive Action (CAPA) process and ensure timely follow-up, and implementation of corrective actions.
• Conduct Quality System Audits and assure corrective action is performed.
• Assume responsibility for management of regulatory submissions and coordinating drafting, editing, and preparation of regulatory submissions (including routine correspondence, INDs, BLAs, NDAs, DMFs, Annual Reports, Amendments, Supplements, Orphan Drug Applications, etc.) 

Requirements

• Minimum ten years previous experience within the FDA and/or working in an FDA-regulated company with primary responsibility for and demonstrable success of obtaining FDA CBER approvals.
• Requires expert knowledge regarding the Center for Biologics Evaluation and Research Organization within the Food and Drug Administration.
• Maintain a working knowledge of published regulations and any changes for all regulatory agencies, particularly the Center for Biologics Evaluation and Research Organization; will require continuous education (e.g. attending seminars/ classes, certification/ recertification).
• Strong communication skills - able to challenge, influence, and articulate a view and drive behavior or action and train employees.
• Self-starter who works with a sense of urgency and acts as a good team player working with other disciplines.
• Requires working knowledge of medical and/ or veterinary medical and biology principles. 

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

December 21, 2011

Title:

CDC Specialist, XenoLung

Job Type:

Full-Time Position

Job Category:

Regulatory

Location:

Silver Spring, MD

Experience Required:

Minimum ten years experience with the CDC or in a CDC-related company with responsibility for public health regulations

Education Level:

Bachelor’s degree in Regulatory Affairs and/ or Health (e.g. Veterinary Medicine, Internal Medicine or Public Health), Science (e.g. Biology, Infectious Diseases, Epidemiology or Genetics) or related field; post graduate degree in Public Health.

Role Purpose/Position Overview

Key Accountabilities/Responsibilities

• Draft guidelines for advanced donor screening and more organ testing to help protect patients from infections transmitted through transplants.
• Oversee the regulation process for products requiring governmental approval, including filing necessary applications and handling all government interactions.
• Perform quality audits/ write improvement plans, reliability engineering, fault analysis and troubleshooting, corrective action tracking and quality management training.
• Manage complaint handling, reporting, vigilance reporting, field actions, and label control.
• Development of clinical investigation plans, Case Report Forms and conduct of monitoring in compliance with GCP’s and ISO, CE FDA, etc. regulations.
• Ensure the proper processes, policies and procedures are in place to obtain necessary regulatory approvals and maintain regulatory compliance.
• Monitor external regulatory developments, identify risks, and communicate potential issues to senior management.
• Assure all regulatory submissions are accurate and submitted in a timely manner and determine if regulatory submissions are required or if a memo-to-file is adequate.
• Assure all marketing, sales and other materials (e.g. labels) and practices are in conformance with regulatory requirements.
• Development and execution of clinical investigation training for investigators, site personnel, and internal Xeno Lung clinical applications support personnel in compliance with good clinical practices.
• Assure compliance with all related regulations governing conduct of clinical investigations including financial disclosure.
• Administration of ongoing relationships with Institutional Review Boards, Ethics Committees, and country competent authorities including ongoing reporting obligations for continuing studies, FDA clinical trials registry requirements, and other applicable regulations.
• Assist in the planning and budgeting for clinical investigations supportive to product development objectives.
• Coordinate inspection of the organization and contract facilities, and develops procedures to ensure regulatory compliance.
• Generate reports, utilizing statistics, as appropriate, to evaluate trends and to aid management in the identification and resolution of issues and overall quality improvement effort.  Recommend KPI’s to measure compliance with quality standards and effectiveness of corrective actions across all functions.
• Assure control and proper disposition of nonconforming products and corrective actions.
• Maintain Corrective & Preventive Action (CAPA) process and ensure timely follow-up, and implementation of corrective actions.
• Conduct Quality System Audits and assure corrective action is performed.
• Assume responsibility for management of regulatory submissions and coordinating drafting, editing, and preparation of regulatory submissions

Requirements

• Minimum ten years experience with the CDC or in a CDC-related company with responsibility for public health regulations.
• Maintain a working knowledge of published regulations and any changes for all regulatory agencies, particularly the Center for Disease Control and Prevention; will require continuous education (e.g. attending seminars/ classes, certification/ recertification).
• Strong communication skills - able to challenge, influence, and articulate a view and drive behavior or action and train employees.
• Self-starter who works with a sense of urgency and acts as a good team player working with other disciplines.
• Requires working knowledge of medical and/ or veterinary medical and biology principles.
• Must be eligible for U.S. Citizenship and able to acquire clearance for the National Agency Check and Inquiries (NACI).
• Extensive knowledge of:  FDA (including GMP and (particularly the safety, purity, potency, and effectiveness of biological products including vaccines, blood and blood products, and cells, tissues, and gene therapies for the prevention, diagnosis, and treatment of human diseases, conditions, or injury, and methods used to defend the public against the threats of emerging infectious diseases and bioterrorism), Center for Disease Control and Prevention within the Department of Health and Human Services.
• Experience with medical devices; Implant and transplant experience preferred.
• A proven ability to deliver value in the following areas: supplier quality audits/improvement plans, reliability engineering, fault analysis and troubleshooting, corrective action tracking and quality management training.
• Strong track record of collaborative working relationship with FDA, ISO and Center for Disease Control and Prevention within the Department of Health and Human Services; FDA or Center for Disease Control and Prevention on-site audit experience preferred.
• Ability to manage and report on projects and drive them to conclusion.
• A passion for helping to cure end-stage lung disease by creating an unlimited supply of transplantable lungs sourced from miniature swine that are genetically modified, designated pathogen free (DPF) and part of a pre-treatment regimen that maximizes human tolerability with minimum immunosuppression 

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

December 02, 2011

Title:

CVM Specialist, XenoLung

Job Type:

Full-Time Position

Job Category:

Regulatory

Location:

Silver Spring, MD

Experience Required:

Minimum ten years previous experience within the FDA and/or working in an FDA-regulated company

Education Level:

Bachelor’s of Science and DVM degrees required

Role Purpose/Position Overview

This position will be primarily responsible for obtaining all necessary regulatory approvals for United Theraepeutics’ xenograft program concerning the Center for Biologics Evaluation and Research Organization (CBER) within the FDA. 

Key Accountabilities/Responsibilities

Responsibilities include:

• Oversee the regulation process for products requiring governmental approval, including filing necessary applications and handling all government interactions.
• Perform quality audits/ write improvement plans, reliability engineering, fault analysis and troubleshooting, corrective action tracking and quality management training.
• Manage complaint handling, reporting, vigilance reporting, field actions, and label control.
• Development of clinical investigation plans, Case Report Forms and conduct of monitoring in compliance with GCP’s and ISO, CE FDA, etc. regulations.
• Ensure the proper processes, policies and procedures are in place to obtain necessary regulatory approvals and maintain regulatory compliance.
• Monitor external regulatory developments, identify risks, and communicate potential issues to senior management.
• Assure all regulatory submissions are accurate and submitted in a timely manner and determine if regulatory submissions are required or if a memo-to-file is adequate.
• Assure all marketing, sales and other materials (e.g. labels) and practices are in conformance with regulatory requirements.
• Development and execution of clinical investigation training for investigators, site personnel, and internal Xeno Lung clinical applications support personnel in compliance with good clinical practices.
• Assure compliance with all related regulations governing conduct of clinical investigations including financial disclosure.
• Administration of ongoing relationships with Institutional Review Boards, Ethics Committees, and country competent authorities including ongoing reporting obligations for continuing studies, FDA clinical trials registry requirements, and other applicable regulations.
• Assist in the planning and budgeting for clinical investigations supportive to product development objectives.
• Coordinate inspection of the organization and contract facilities, and develops procedures to ensure regulatory compliance.
• Generate reports, utilizing statistics, as appropriate, to evaluate trends and to aid management in the identification and resolution of issues and overall quality improvement effort.  Recommend KPI’s to measure compliance with quality standards and effectiveness of corrective actions across all functions.
• Assure control and proper disposition of nonconforming products and corrective actions.
• Maintain Corrective & Preventive Action (CAPA) process and ensure timely follow-up, and implementation of corrective actions.
• Conduct Quality System Audits and assure corrective action is performed.
• Assume responsibility for management of regulatory submissions and coordinating drafting, editing, and preparation of regulatory submissions (including routine correspondence, INDs, BLAs, NDAs, DMFs, Annual Reports, Amendments, Supplements, Orphan Drug Applications, etc.) 

Requirements

• Minimum ten years previous experience within the FDA and/or working in an FDA-regulated company with primary responsibility for and demonstrable success of obtaining FDA veterinary medicine approvals.
• Requires expert knowledge regarding the Center for Veterinary Medicine within the Food and Drug Administration.
• Maintain a working knowledge of published regulations and any changes for all regulatory agencies, particularly the Center for Veterinary Medicine; will require continuous education (e.g. attending seminars/ classes, certification/ recertification).
• Strong communication skills - able to challenge, influence, and articulate a view and drive behavior or action and train employees.
• Self-starter who works with a sense of urgency and acts as a good team player working with other disciplines.
• Requires working knowledge of medical and/ or veterinary medical principles.

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

February 03, 2012

Title:

Clinical Quality Assurance Manager

Job Type:

Full-Time Position

Job Category:

Quality

Location:

Silver Spring, MD

Experience Required:

Five or more years of direct pharmaceutical QA GCP experience is required. GLP experience is a plus.

Education Level:

Minimum BS Degree in a scientific or related discipline

Role Purpose/Position Overview

This individual is responsible for the management of the Clinical Quality Assurance function in line with strategies and goals set by management. Ensures clinical research activities conform to federal and international regulations as well as to our internal procedures and expectations. 

Key Accountabilities/Responsibilities

• Develops Quality Assurance Standard Operating Procedures and policies and coordinates the company SOP development and maintenance process to ensure compliance with federal and international regulations.
• Develops, performs, and manages an auditing program that will ensure compliance with federal and international regulations and company policies.
• Audits will include internal system and documentation audits as well as external audits of clinical sites, CROs, bioanalytical laboratories and other vendors.
• Manages regulatory agency and other audits/inspections of Lung Rx offices and prepares investigator sites for FDA or other regulatory agency inspections.
• Assists in preparing audit responses and evaluating adequacy of corrective actions.
• Oversees internal training, including regulatory and compliance training.
• Serves as in-house consultant for understanding project-specific requirements regarding national, regional, and local laws and regulations (e.g., privacy, data protection, and ethics) and ensuring compliance.
• Conducts pre- and post-study document reviews and takes corrective action.
• Monitors compliance with all regulatory requirements for the protection of human subjects.
• Establish and maintains clinical quality database of observations for quality analysis and assessment and identifies compliance risks.

Requirements

• The right candidate will have experience performing process and documentation audits; experience developing process documentation.
• Ability to understand and interpret national, regional, and local regulations.
• International experience is a plus.
• Computer literacy with experience in Microsoft software suite and other relevant packages.
• Travel (domestic and international) to conduct site and vendor compliance audits and attend meetings is required.

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

December 02, 2011

Title:

Community Relations Specialist, XenoLung

Job Type:

Full-Time Position

Job Category:

Sales & Marketing

Location:

Silver Spring, MD

Experience Required:

Five years+ previous experience in Communications, Public Relations, and/or Community Relations for high technology projects.

Education Level:

Bachelor's Degree in public health, bioethics or related field; graduate degree a plus.

Role Purpose/Position Overview

The individual in this position will manage Xeno Lung’s public image and cultivate community contacts to increase awareness and collaborative opportunities.  Primary responsibilities include organizing volunteers, coordinating special events, implementing community outreach programs and managing online social media networking.

Key Accountabilities/Responsibilities

Responsibilities include:

• Plan, implement and analyze public relations and marketing strategies that advance Xeno Lung’s mission and goals to cure end-stage lung disease by creating an unlimited supply of transplantable lungs sourced from swine that are genetically modified, designated pathogen free (DPF) and part of a pre-treatment regimen that maximizes human tolerability with minimum immunosuppression.
• Event planning, volunteer coordination and community outreach programs.
• Potentially draft press releases and contact persons in the media to broadcast or print their material.
• Nurture connections with patients and businesses and organizations that help support company goals and to create community awareness by managing and utilizing social media and other means of communication.
• Track, report and manage progress regarding community relations.

Requirements

• Five years+ previous experience in Communications, Public Relations, and/or Community Relations for high technology projects 
• Experienced public speaker and presenter; particularly large groups.
• Highly organized self-starter. 
• Ability to operate Apple and/ or PC; Advanced Microsoft Office Suite (2007 and 2010) skills: Word, Excel, Outlook, PowerPoint, Project required, as well as Adobe Acrobat, Visio and excellent data entry skills.
• Experienced in data analysis systems, utilizing the internet and social media.

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

December 21, 2011

Title:

DPF Animal Operations Specialist, XenoLung

Job Type:

Full-Time Position

Job Category:

Clinical Operations

Location:

Silver Spring, MD

Experience Required:

Minimum of five years experience managing design, development, validation, regulatory approval and commercial operation of a biological drug production facility. Experience with use of animal production biological a plus

Education Level:

Bachelor's Degree in Health (e.g. BSN, Public Health), Science (e.g. Biology, Genetics) or related field, post graduate degree in relevant field, All certifications/ licensure necessary and relevant to perform job duties. • All certifications/ licensure necessary and relevant to perform job duties.

Role Purpose/Position Overview

The individual in this position will assist managing the design, development, validation, regulatory approval and commercial operation of the XenoLung organ production facility.

Key Accountabilities/Responsibilities

• Serve as lead contact for organ production administration and coordination and ensures consistency regarding explanation policies/procedures. [Provide overall administrative direction and coordination for clinical policies, procedures and programs].
• Collaborate with medical and surgical leadership on administration of high functioning, highly efficient, outcomes driven, value creating programs.
• Monitor organ production services to insure optimal business performance across multiple departments and divisions.
• Analyze, plan and strategize the formation of Xeno Lung program goals, as well as practice operations and activities. 
• Develop supporting policies and procedures.
• Manage and coordinate Xeno Lung efforts to ensure performance management and quality improvement programs are developed and managed using a data-driven focus, setting priorities for improvement(s) aligned to ongoing strategic imperatives.
• Participating in the planning and management of investigator meetings, advisory boards and other scientific committees.
• Providing strategic input into clinical/regulatory development plans.
• Writing/reviewing clinical trial protocols, study reports, and international regulatory documents.
• Working actively with the study team reviewing study data and ensuring data quality.
• Provide overall administrative direction and coordination for clinical policies, procedures and programs.
• Analyze, plan and strategize the formation of clinical program goals, as well as practice operations and activities.  Will participate in this
• Develop supporting policies and procedures.
• Manage and coordinate Xeno Lung efforts to ensure performance management and quality improvement programs are developed and managed using a data-driven focus, setting priorities for improvement(s) aligned to ongoing strategic imperatives.
• Address and resolve medical/safety/eligibility questions from participating clinical trial sites.
• Participate in the planning and management of investigator meetings, advisory boards and other scientific committees.
• Providing strategic input into clinical/regulatory development plans.
• Work actively with the study team reviewing study data and ensuring data quality.
• Implement Adverse Event Reporting protocols and safety responsibilities monitoring. 
• Coordinate and develop information for reports submitted to the Food and Drug Administration, EMEA and other international regulatory agencies. 
• Monitor adherence to protocols and determine study completion. 
• Integrate medical and scientific data pertaining to efficacy, safety and dosage, from discovery to post-marketing, to develop and sustain innovative, consistent and clear strategy.
• Manage input on company position on scientific and medical content.
• Provide medical and scientific guidance to innovation targets, clinical trial strategy and design; approval of promotional materials in compliance with corporate standards, government/industry regulations (with the assistance of regulatory affairs).
• Serve on Internal Advisory Committee preparatory team.
• Monitor industry trends; anticipate future changes in marketplace and take action to create long-term opportunities and value.
• Accountable for providing strategic, scientific expertise to quantify the benefit, risk, value and uncertainty of the emerging product profile throughout the lifecycle of the organ production process.
• Lead the thought process and contributions to the creation and development of target claims, benefit/risk/value assessment, branding and clinical development plans, Regulatory strategy, health technology assessment and Commercial exploration of Xeno Lung products.
• Actively contribute to the discovery, development and delivery of Xeno Lung products to our patients and customers.

Requirements

• Minimum of five years experience managing design, development, validation, regulatory approval and commercial operation of a biological drug production facility. Experience with use of animal production biological a plus
• Expert knowledge and skills necessary to provide care and/or interact appropriately to the ages of the patients served by his/her assigned unit as specified below. 
•  Ability to evaluate staff, address and improve clinical issues and devise solutions to complex problems. 
• Expert knowledge of the principles of growth and development over the life span and possess the ability to assess data reflective of the patient's status and interpret the appropriate information needed to identify each patient's requirements relative to his/her age-specific needs and to provide the care needs as described in the department policy and procedures.
• All certifications/ licensure necessary and relevant to perform job duties. 
• American Board for Transplant Certification, ABTC strongly preferred.
• Ability to operate Apple and/ or PC; Advanced Microsoft Office Suite (2007 and 2010) skills: Word, Excel, Outlook, PowerPoint, Project required, as well as Adobe Acrobat and excellent data entry skills.
• 25 % travel required.
• Strong verbal and written communication skills, excellent troubleshooting and relationship-building skills.
• Ability to work effectively in a team environment with both local and remote team members, and as individual.
• Ability to deal with various skill/ technical levels of business acumen.
• Strong decision-making and judgment skills, as well as excellent research, analytical and problem-solving skills.
• Ability to focus on goals and anticipate/ reduce risk.
• Work together with the Project team and business stakeholders to translate business processes into systems functionality.
• Must have a passion for helping to cure end-stage lung disease by creating an unlimited supply of transplantable lungs sourced from miniature swine that are genetically modified, designated pathogen free (DPF) and part of a pre-treatment regimen that maximizes human tolerability with minimum immunosuppression.

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

December 09, 2011

Title:

DPF Animal Welfare Specialist, XenoLung

Job Type:

Full-Time Position

Job Category:

Clinical Operations

Location:

Silver Spring, MD

Experience Required:

Minimum of ten years experience successfully operating a CVM regulated facility with responsibility for animal welfare and compliance with federal regulations governing laboratory animals.

Education Level:

Bachelor’s degree in a closely related Health or Science field and DVM required.

Role Purpose/Position Overview

The individual in this position will perform the necessary duties to provide quality care to all animals utilized in research and organ production in accordance with a all requlatory (e.g., CVM) requirements.

Key Accountabilities/Responsibilities

Responsibilities include:

• Follow set procedures as dictated by federal regulations governing laboratory animals.
• Conduct physical examinations, administer medications and treatments; diagnose health problems, review medical history records; conduct physical examinations and treatments; clean and suture wounds; calculate appropriate drug doses; perform routine diagnostic lab tests; report laboratory test results to appropriate parties; maintain the cleanliness and orderliness of the animal care facility.
• Provide and/or oversee laboratory, research, or animal care support for animals, such as feeding and grooming.
• Conduct routine tests, compile data and maintain quality control, collect and prepare samples.
• Responsible for total functions of laboratory units, research projects, writing research papers as author or co-author, generate reports, research literature related to project/procedures, provide input and/ or write segments of reports and manuscripts.
• Coordinate and prepare grant proposals and budgets.
• Receive, distribute and prepare packages, samples and supplies.
• Prepare sample test kits and media.
• Report laboratory, autopsy and necropsy procedures impact outcomes of tests and research, and impact the safety, health, and well-being of laboratory animals.
• Analysis and compilation of data, communicate findings/research results, maintain equipment and order supplies. 

Requirements

• Minimum of ten years experience successfully operating a CVM regulated facility with responsibility for animal welfare and compliance with federal regulations governing laboratory animals.
• Strong verbal and written communication skills (allows one to obtain family histories and interpret these findings), excellent troubleshooting and relationship-building skills; ability to work with people and families in highly stressful and emotional situations. Ability to work with other professionals in a clinical setting.
• Ability to work effectively in a team environment with both local and remote team members, and as individual or with minimal supervision.
• Ability to deal with various skill/ technical levels of business acumen.
• Strong decision-making and judgment skills, as well as excellent research, analytical and problem-solving skills.
• Ability to focus on goals and anticipate/ reduce risk.
• Requires critical thinking, organizational skills, decisive judgment, analytical problem solving, communication, and good customer service skills.
• Expert knowledge of genetic principles.
• Experience with family history software is highly preferred.
• Experience with Waters Empower, Perkin Elmer Spectrum ES and SLIM software is highly preferred.
• Ability to operate Apple and/ or PC; Advanced Microsoft Office Suite (2007 and 2010) skills: Word, Excel, Outlook, PowerPoint, Project required, as well as Adobe Acrobat, Visio and excellent data entry skills .

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

December 09, 2011

Title:

DPF Architecture & Design Specialist, XenoLung

Job Type:

Full-Time Position

Job Category:

Research & Development

Location:

Silver Spring, MD

Experience Required:

Minimum ten years experience managing the design and development of a biological drug production facility.

Education Level:

Bachelor’s and post graduate degree in relevant field required.

Role Purpose/Position Overview

The individual in this position will be manage the design and development of a designated pathogen free (DPF) facility that will be used to produce genetically modified pigs for use in United Therapeutics’ xenotransplantation program.

Key Accountabilities/Responsibilities

Responsibilities include:

• Provide architectural and design expertise for a DPF facility and manage the construction process.
• Study effects of management practices, processing methods, feed, or environmental conditions on quality and quantity of product; Develop improved practices in feeding, housing, sanitation, or parasite and disease control of animals.
• Research and control nutritional requirements of animals, nutritive values of animal feed materials, breeding, or management to improve products or processes as well as animal selection and breeding practices to increase production efficiency and improve animal quality.
• Maintains knowledge of and compliance with the "Guide for the Care and Use of Laboratory Animals," USDA guidelines as well as all other institutional, local, state and federal regulations concerning the use of animals in research.
• Ensure proper habitat labeling to include information regarding strain or lineage, sex and maturity of mice and rats; update information as necessary.
• Maintain calendars and detailed breeding and production records to indicate birth dates, animal age, and fertility data of each animal; responsible for computerized or manual pairing records to maintain pedigree information on each animal; assess recurrence and occurrence of conditions, nature of the condition, mode of inheritance, recurrence risk, treatments, prognosis, available services and support groups.
• Monitor environmental parameters and maintain written records, including room temperatures, light cycles and sanitation; report problems to management.
• Evaluate and gather genetic risk assessment tools for monogenic and complex diseases particularly end-stage lung disease.
• Coordinate and supervise clinical aspects of the development, implementation, and validation of multiple disease family history and risk assessment tools.
• Compilation of the quarterly progress form to report statistics to the Director of Organ Production, the Organ Production team, key stake holders and upper-level management. 

Requirements

• Minimum ten years experience managing the design and development of a biological drug production facility.
• Knowledge of science (biological and chemical) and health principles.
• Understanding of regulatory requirements to ensure facility remains sterile.
• Proven ability to collect information from relevant sources and analyze data; understanding of anatomical and physiological differences of laboratory animals and ability to recognize changes or abnormalities in eating habits, feces, urine and behavior.
• Strong verbal and written communication skills (allows one to obtain family histories and interpret these findings), excellent troubleshooting and relationship-building skills; ability to work with people and families in highly stressful and emotional situations. Ability to work with other professionals in a clinical setting.
• Ability to work effectively in a team environment with both local and remote team members, and as individual or with minimal supervision.
• Ability to deal with various skill/ technical levels of business acumen.
• Strong decision-making and judgment skills, as well as excellent research, analytical and problem-solving skills.
• Ability to focus on goals and anticipate/ reduce risk.
• Requires critical thinking, organizational skills, decisive judgment, analytical problem solving, communication, and good customer service skills.
• Expert knowledge of medical and diagnostic equiptment required.
• Experience with family history software is highly preferred.
• Experience with Waters Empower, Perkin Elmer Spectrum ES and SLIM software is highly preferred.
• Ability to operate Apple and/ or PC; Advanced Microsoft Office Suite (2007 and 2010) skills: Word, Excel, Outlook, PowerPoint, Project required, as well as Adobe Acrobat, Visio and excellent data entry skills

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

December 09, 2011

Title:

DPF Surgical Operations Specialist, XenoLung

Job Type:

Full-Time Position

Job Category:

Clinical Operations

Location:

Silver Spring, MD

Experience Required:

Minimum ten years experience successfully managing the commercial operation of an animal surgery facility regulated by the CVM, and in full compliance with federal laboratory animal regulations.

Education Level:

Bachelor’s degree from an accredited institution in health or science (e.g. Genetics, Animal Nutrition or Zoology, Chemistry, Biochemistry) and Doctorate of Veterinary Medicine (DVM) required.

Role Purpose/Position Overview

The individual in this position will manage the commercial operation of xenotransplantation program animal surgery facility, conducting transplantations of XenoLungs from pigs. This will be accomplished in full compliance with CVM and all federal laboratory animal regulations.

Key Accountabilities/Responsibilities

Responsibilities include:

• Follow set procedures as dictated by the National Institute of Health Guide for the Care and Use of Animals, the Animal Welfare Act and guidelines established by the Institutional Animal Care and Use Committee and the Association for Assessment and Accreditation of Laboratory Animal Care.
• Assist, coordinate and perform transplant surgery; perform protocol sample collections of blood, body fluids and tissue and processes for histology, nucleic acid procurement and serologic tests; perform protocol related medication dosing, biopsies, and diagnostic studies.
•  Maintain animal records in keeping with applicable IACUC requirements and supervise the record keeping; maintain a record of all procedures, animal use, protocol compliance and integrity of the animal database.
• Coordinate animal procurement and procedures.
• Responsible for total functions of laboratory units, research projects, writing research papers as author or co-author, generate reports, research literature related to project/procedures, provide input and/ or write segments of reports and manuscripts.
• Coordinate and prepare grant proposals and budgets.
• Report laboratory, autopsy and necropsy procedures impact outcomes of tests and research, and impact the safety, health, and well-being of laboratory animals.
• Analyze and compile data, communicate findings/research results, maintain equipment and order supplies. 

Requirements

• Minimum ten years experience successfully managing the commercial operation of an animal surgery facility regulated by the CVM, and in full compliance with federal laboratory animal regulations.
• Expert knowledge of science, health and laboratory principles; knowledge of basic sanitation techniques, laboratory safety procedures, research procedures, animal handling/care, hygiene and welfare, and use of laboratory, medical and diagnostic equipment. 
• Strong verbal and written communication skills (allows one to obtain family histories and interpret these findings), excellent troubleshooting and relationship-building skills; ability to work with people and families in highly stressful and emotional situations. Ability to work with other professionals in a clinical setting.
• Ability to work effectively in a team environment with both local and remote team members, and as individual or with minimal supervision.
• Ability to deal with various skill/ technical levels of business acumen.
• Strong decision-making and judgment skills, as well as excellent research, analytical and problem-solving skills.
• Ability to focus on goals and anticipate/ reduce risk.
• Requires critical thinking, organizational skills, decisive judgment, analytical problem solving, communication, and good customer service skills.
• Expert knowledge of genetic principles.
• Experience with family history software is highly preferred.
• Experience with Waters Empower, Perkin Elmer Spectrum ES and SLIM software is highly preferred.
• Ability to operate Apple and/ or PC; Advanced Microsoft Office Suite (2007 and 2010) skills: Word, Excel, Outlook, PowerPoint, Project required, as well as Adobe Acrobat, Visio and excellent data entry skills .

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

December 21, 2011

Title:

Deputy Project Leader, XenoLung

Job Type:

Full-Time Position

Job Category:

Research & Development

Location:

Silver Spring, MD

Experience Required:

Relevant experience could include: Military experience (Lt. Col or higher); Program leader for military’s biotechnology advancement or vaccine production initiatives; DARPA program manager experience in DSO. Familiarity with medical and/or transplantation field and FDA regulatory process.

Education Level:

PhD or equivalent in life sciences field

Role Purpose/Position Overview

Key Accountabilities/Responsibilities

Planning

Collaborates with Head of Xenoto develop strategies for achieving goal of developing a Xenolung by the end of the decade.

Creates annual operating plans that support strategic direction and correlate with annual operating budgets; submits annual plans to the Head of Xeno for approval.

Develops and monitors initiatives, milestones and timelines associated with Xenloung Project.

Builds organizational capabilities and resources to support research, development and regulatory requirements along critical path to a Xenolung (i.e. staffing, technology, facilities/sites, etc.).

Management

Oversees/directs the operations of the Xenolung Project and manages its compliance with legal and regulatory requirements.

Hires and manages the employees needed to achieve our goals, in collaboration and consistent with HR policies and procedures.

Evaluates the Xenolung Project’s and the staff’s performance on a regular basis to ensure successful executive of the strategy

Program Effectiveness

Oversees/directs design, delivery, and quality of xenolung development consistent with overall strategy, milestones and timelines

Stays abreast of current trends and developments related to xenotransplantation products and services and anticipates future trends likely to have an impact on the Xenolung Project.

Collects and analyzes evaluation information that measures the success of the Xenolung Project; refines or changes programs in response to that information

Production

Responsible for establishment of a Xenolung Production facility that will meet FDA or equivalent standards for approval and has capability to produce and deliver to nationwide transplantation centers thousands of xenolungs per year.

Financial Stewardship

Oversees staff in developing annual budgets that support operating plans and submits budgets to Head of Xeno for approval.

Prudently manages the unit’s resources within budget guidelines

Requirements

Management and oversight of Apollo Lung business unit which is likely to include (when fully developed):

• 7 to 10 direct reports and 300+ employees
• Responsible for setting goals for each direct report
• Responsible for the evaluation of performance of each direct report, performance planning and professional development
• Responsible for general assessment of remaining department personnel goals and performance
• Ensure appropriate performance management of all xenotransplantation team members.
• Direct responsibility of assigned xenolung development budgets.  Responsibilities include annual forecasting, oversight of day-to-day spending and ensuring compliance with company procedures (e.g., PO’s).
• English, fluency in second language (preferably Chinese) a plus
• MS Office Suite, email and Internet
• Ability to travel as needed (25%)
• Strong verbal and written communication skills, excellent troubleshooting and relationship-building skills.
• Ability to work effectively in a team environment with both local and remote team members, and as individual.
• Ability to deal with various skill/ technical levels of business acumen.
• Strong decision-making and judgment skills, as well as excellent research, analytical and problem-solving skills.
• Ability to focus on goals and anticipate/ reduce risk.
• Work together with the Project team and business stakeholders to translate business processes into systems functionality.

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

December 02, 2011

Title:

Director, XenoLung Clinical Development

Job Type:

Full-Time Position

Job Category:

Clinical Operations

Location:

Silver Spring, MD

Experience Required:

Minimum ten years industry experience developing clinical trials for biologic compound

Education Level:

Ph.D in Pharmacology, Biochemistry or related field

Role Purpose/Position Overview

This position will be charged with developing the clinical trial strategy and then managing, coordinating and evaluating all aspects of the clinical development process for the xenograft program.

Key Accountabilities/Responsibilities

Responsibilities include:

• Provide overall administrative direction and coordination for clinical policies, procedures and programs.
• Analyze, plan and strategize the formation of clinical program goals, as well as practice operations and activities. 
• Develop supporting policies and procedures.
• Manage and coordinate Xeno Lung efforts to ensure performance management and quality improvement programs are developed and managed using a data-driven focus, setting priorities for improvement(s) aligned to ongoing strategic imperatives.
• Addressing and resolving medical/safety/eligibility questions from participating clinical trial sites.
• Participating in the planning and management of investigator meetings, advisory boards and other scientific committees.
• Providing strategic input into clinical/regulatory development plans.
• Writing/reviewing clinical trial protocols, study reports, and international regulatory documents.
• Working actively with the study team reviewing study data and ensuring data quality.
• Collaborating with pre-clinical and translational medicine colleagues in assessing the potential of new compounds for development.
• Directing human clinical trials, Phases I – IV, for Xeno Lung products under development. 
• Implement Adverse Event Reporting protocols and safety responsibilities monitoring. 
• Coordinating and developing information for reports submitted to the Food and Drug Administration, EMEA and other international regulatory agencies. 
• Monitoring adherence to protocols and determines study completion. 
• Selecting, developing and evaluating personnel to ensure the efficient operation of the function.
• Integrate medical and scientific data pertaining to efficacy, safety and dosage, from discovery to post-marketing, to develop and sustain innovative, consistent and clear strategy.
• Manage input on company position on scientific and medical content.
• Provide medical and scientific guidance to innovation targets, clinical trial strategy and design; product labeling and approval of promotional materials in compliance with corporate standards, government/industry regulations (with the assistance of regulatory affairs).
• Internal Advisory Committee preparatory team.
• Monitor industry trends; anticipate future changes in marketplace and take action to create long-term opportunities and value.

Requirements

• Minimum ten years industry experience developing clinical trials for biologic compound
• Key member of team that successfully obtained FDA approval of a biologic compound
• Strong verbal and written communication skills, excellent troubleshooting and relationship-building skills.
• Ability to work effectively in a team environment with both local and remote team members, and as individual.
• Ability to deal with various skill/ technical levels of business acumen.
• Strong decision-making and judgment skills, as well as excellent research, analytical and problem-solving skills.
• Ability to focus on goals and anticipate/ reduce risk.
• Work together with the Clinical Development team and business stakeholders to translate business processes into systems functionality.
• Ability to operate Apple and/ or PC; Advanced Microsoft Office Suite (2007 and 2010) skills: Word, Excel, Outlook, PowerPoint, Project required, as well as Adobe Acrobat, Visio and excellent data entry skills.

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

December 09, 2011

Title:

Director, XenoLung Organ Development

Job Type:

Full-Time Position

Job Category:

Clinical Operations

Location:

Silver Spring, MD

Experience Required:

Minimum of ten years experience managing design, development, validation, regulatory approval and commercial operation of a biological drug production facility.

Education Level:

Bachelor's Degree in Health (e.g. BSN, Public Health), Science (e.g. Biology, Genetics) or related field, post graduate degree in relevant field

Role Purpose/Position Overview

The individual in this position will manage the design, development, validation, regulatory approval and commercial operation of the XenoLung organ production facility.

Key Accountabilities/Responsibilities

Responsibilities include:

• Serve as lead contact for organ production administration and coordination and ensures consistency regarding explantation policies/procedures. [Provide overall administrative direction and coordination for clinical policies, procedures and programs].
• Collaborate with medical and surgical leadership on administration of high functioning, highly efficient, outcomes driven, value creating programs.
• Monitor organ production services to insure optimal business performance across multiple departments and divisions.
• Analyze, plan and strategize the formation of Xeno Lung program goals, as well as practice operations and activities. 
• Develop supporting policies and procedures.
• Manage and coordinate Xeno Lung efforts to ensure performance management and quality improvement programs are developed and managed using a data-driven focus, setting priorities for improvement(s) aligned to ongoing strategic imperatives.
• Participating in the planning and management of investigator meetings, advisory boards and other scientific committees.
• Providing strategic input into clinical/regulatory development plans.
• Writing/reviewing clinical trial protocols, study reports, and international regulatory documents.
• Working actively with the study team reviewing study data and ensuring data quality.
• Provide overall administrative direction and coordination for clinical policies, procedures and programs.
• Analyze, plan and strategize the formation of clinical program goals, as well as practice operations and activities.  Will participate in this
• Develop supporting policies and procedures.
• Manage and coordinate Xeno Lung efforts to ensure performance management and quality improvement programs are developed and managed using a data-driven focus, setting priorities for improvement(s) aligned to ongoing strategic imperatives.
• Address and resolve medical/safety/eligibility questions from participating clinical trial sites.
• Participate in the planning and management of investigator meetings, advisory boards and other scientific committees.
• Providing strategic input into clinical/regulatory development plans.
• Work actively with the study team reviewing study data and ensuring data quality.
• Implement Adverse Event Reporting protocols and safety responsibilities monitoring. 
• Coordinate and develop information for reports submitted to the Food and Drug Administration, EMEA and other international regulatory agencies. 
• Monitor adherence to protocols and determine study completion. 
• Integrate medical and scientific data pertaining to efficacy, safety and dosage, from discovery to post-marketing, to develop and sustain innovative, consistent and clear strategy.
• Manage input on company position on scientific and medical content.
• Provide medical and scientific guidance to innovation targets, clinical trial strategy and design; approval of promotional materials in compliance with corporate standards, government/industry regulations (with the assistance of regulatory affairs).
• Serve on Internal Advisory Committee preparatory team.
• Monitor industry trends; anticipate future changes in marketplace and take action to create long-term opportunities and value.
• Accountable for providing strategic, scientific expertise to quantify the benefit, risk, value and uncertainty of the emerging product profile throughout the lifecycle of the organ production process.
• Lead the thought process and contributions to the creation and development of target claims, benefit/risk/value assessment, branding and clinical development plans, Regulatory strategy, health technology assessment and Commercial exploration of Xeno Lung products.

Requirements

• Minimum of ten years experience managing design, development, validation, regulatory approval and commercial operation of a biological drug production facility. Experience with use of animal production biological a plus
• Expert knowledge and skills necessary to provide care and/or interact appropriately to the ages of the patients served by his/her assigned unit as specified below. 
• Ability to evaluate staff, address and improve clinical issues and devise solutions to complex problems. 
• Expert knowledge of the principles of growth and development over the life span and possess the ability to assess data reflective of the patient's status and interpret the appropriate information needed to identify each patient's requirements relative to his/her age-specific needs and to provide the care needs as described in the department policy and procedures.

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

December 02, 2011

Title:

Director, XenoLung Preclinical Studies

Job Type:

Full-Time Position

Job Category:

Clinical Operations

Location:

Silver Spring, MD

Experience Required:

Minimum ten years experience in Pharmaceutical or Biotech Industry working in preclinical research and development for biologicals.

Education Level:

Ph.D in life sciences or field relevant to pre-clinical studies in biologic compounds.

Role Purpose/Position Overview

This position will serve as director for preclinical XenoLung studies. Leads, directs and executes XenoLung preclinical investigations and IND-enabling studies necessary to advance the XenoLung to clinical development .  

Key Accountabilities/Responsibilities

Responsibilities include:

• Determines and pursues courses of action necessary to meet the goals and objectives of the Preclinical team in regard to policies, procedures and programs.
• Analyze, plan and strategize the formation of preclinical practice operations and activities.
• Develops schedule, timelines and budget projections and manages preclinical resources of projects as well as provides formal and informal progress reports (both vertical and horizontal) to management.
• Plans, develops and manages preclinical animal studies to support business strategies to ensure the company meets strategic and tactical goals and adheres to all regulatory and compliance requirements.
• Developing a thorough understanding of preclinical product applications and translating those needs into preclinical safety-and performance-testing strategies.
• Coordinating and developing information for reports submitted to the Food and Drug Administration, EMEA and other international regulatory agencies. 
• Develops preclinical protocols and ensures that execution is in accordance with approved IACUC/animal care committee guidelines.
• Manage and coordinate Xeno Lung efforts to ensure performance management and quality improvement programs are developed and managed using a data-driven focus, setting priorities for improvement(s) aligned to ongoing strategic imperatives.
• Addressing and resolving medical/safety/eligibility questions from participating clinical trial sites.
• Participating in the planning and management of investigator meetings, advisory boards and other scientific committees.
• Providing strategic input into clinical/regulatory development plans.
• Writing/reviewing clinical trial protocols, study reports, and international regulatory documents.
• Working actively with the study team reviewing study data and ensuring data quality.
• Collaborating with pre-clinical and translational medicine colleagues in assessing the potential of new compounds for development. 

Requirements

• Minimum 10+ years experience in Pharmaceutical or Biotech Industry working in preclinical research and development for biologicals.
• Strong verbal and written communication skills, excellent troubleshooting and relationship-building skills.
• Ability to work effectively in a team environment with both local and remote team members, and as individual.
• Ability to deal with various skill/ technical levels of business acumen.
• Strong decision-making and judgment skills, as well as excellent research, analytical and problem-solving skills.
• Ability to focus on goals and anticipate/ reduce risk.
• Work together with the Clinical Development team and business stakeholders to translate business processes into systems functionality.
• A passion for helping to cure end-stage lung disease by creating an unlimited supply of transplantable lungs sourced from miniature swine that are genetically modified, designated pathogen free (DPF) and part of a pre-treatment regimen that maximizes human tolerability with minimum immunosuppression.

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

December 02, 2011

Title:

Director, XenoLung Regulatory Affairs

Job Type:

Full-Time Position

Job Category:

Regulatory

Location:

Silver Spring, MD

Experience Required:

Minimum ten years experience within the FDA and/or working in an FDA-regulated company

Education Level:

Bachelor's of Science and law degree preferred.

Role Purpose/Position Overview

This position will be primarily responsible for obtaining all necessary regulatory approvals for United Theraepeutics’ xenograft program.  

Key Accountabilities/Responsibilities

Responsibilities include:

• Oversee the regulation process for products requiring governmental approval, including filing necessary applications and handling all government interactions.
• Manage complaint handling, medical device reporting, vigilance reporting, field actions, and label control.
• Development of clinical investigation plans, Case Report Forms and conduct of monitoring in compliance with GCP’s and ISO, CE FDA, etc. regulations.
• Ensure the proper processes, policies and procedures are in place to obtain necessary regulatory approvals and maintain regulatory compliance.
• Monitor external regulatory developments, identify risks, and communicate potential issues to senior management.
• Assure all regulatory submissions are accurate and submitted in a timely manner.  Determine if regulatory submissions are required or if a memo-to-file is adequate.
• Assure all marketing, sales and other materials (e.g. labels) and practices are in conformance with regulatory requirements.
• Development and execution of clinical investigation training for investigators, site personnel, and internal Xeno Lung clinical applications support personnel in compliance with good clinical practices.
• Assure compliance with all related regulations governing conduct of clinical investigations including financial disclosure.
• Administration of ongoing relationships with Institutional Review Boards, Ethics Committees, and country competent authorities including ongoing reporting obligations for continuing studies, FDA clinical trials registry requirements, and other applicable regulations.
• Assist in the planning and budgeting for clinical investigations supportive to product development objectives.
• Coordinates inspection of the organization and contract facilities, and develops procedures to ensure regulatory compliance.
• Generate reports, utilizing statistics, as appropriate, to evaluate trends and to aid management in the identification and resolution of issues and overall quality improvement effort.  Recommend KPI’s to measure compliance with quality standards and effectiveness of corrective actions across all functions.
• Assure control and proper disposition of nonconforming products and corrective actions.
• Maintain Corrective & Preventive Action (CAPA) process and ensure timely follow-up, and implementation of corrective actions.
• Conduct Quality System Audits (including international audits) and assure corrective action is performed.
• Assume primary responsibility for management of regulatory submissions and coordinating drafting, editing, and preparation of regulatory submissions (including routine correspondence, INDs, BLAs, NDAs, DMFs, Annual Reports, Amendments, Supplements, Orphan Drug Applications, etc.) 

Requirements

• Minimum ten years previous experience within the FDA and/or working in an FDA-regulated company with primary responsibility for and demonstrable success of obtaining FDA approval of a biologic product.  
• Strong communication skills - able to challenge, influence, and articulate a view and drive behavior or action and train employees.
• Self-starter who works with a sense of urgency and acts as a good team player working with other disciplines.
• Adaptability and resourcefulness to roll-up-sleeves and multi-task in order to thrive in small company environment
• A passion for helping to cure end-stage lung disease by creating an unlimited supply of transplantable lungs sourced from miniature swine that are genetically modified, designated pathogen free (DPF) and part of a pre-treatment regimen that maximizes human tolerability with minimum immunosuppression. 

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

December 02, 2011

Title:

Director, XenoLung Science

Job Type:

Full-Time Position

Job Category:

Clinical Operations

Location:

Silver Spring, MD

Experience Required:

Minimum 10 years experience in basic research related to organ, bone marrow or stem cell transplantation

Education Level:

Ph.D or MD in related scientific field(s)

Role Purpose/Position Overview

This individual will be responsible for leading and managing parallel research efforts in immunology, hepatology and transplantation science with the goal of successful development xenografts for end stage organ disease.

Key Accountabilities/Responsibilities

Responsibilities include:

• Formulate and develop the scientific strategic plan of the company
• Direct the company’s scientific research work in pursuit of the strategy
•  Commission, where appropriate, scientific research in areas consistent with company strategies and in support of the company’s charitable aims.
• Working with Product Management and Business Development, develop, implement and monitor the annual and medium term scientific plans, programs and projects to meet overall strategic objectives and agreed timings.
• Lead and manage the Research team, fostering a team-based culture, ensuring positive interactions with other teams and with UT members.
• Identify scientific opportunities and competitive threats to the underlying Research base of the company.
• Accountable for providing strategic, scientific expertise to quantify the benefit, risk, value and uncertainty of the emerging product profile throughout the lifecycle of the drug development process.
• Lead the thought process and contributions to the creation and development of target claims, benefit/risk/value assessment, branding and clinical development plans, Regulatory strategy, health technology assessment and Commercial exploration of Xeno Lung products.
• Actively contribute to the discovery, development and delivery of Xeno Lung products to our patients and customers. 

Requirements

• Minimum 10 years experience in basic research related to organ, bone marrow or stem cell transplantation
• Management of a team of at least 20 scientists and multiple laboratories
• Strong verbal and written communication skills, excellent troubleshooting and relationship-building skills.
• Ability to work effectively in a team environment with both local and remote team members, and as individual.
• Ability to deal with various skill/ technical levels of business acumen.
• Strong decision-making and judgment skills, as well as excellent research, analytical and problem-solving skills.
• Ability to focus on goals and anticipate/ reduce risk.
• Work together with the Project team and business stakeholders to translate business processes into systems functionality.
• Experienced in data analysis; SharePoint, Oracle, etc. a plus.
• Ability to operate Apple and/ or PC; Advanced Microsoft Office Suite (2007 and 2010) skills: Word, Excel, Outlook, PowerPoint, Project required, as well as Adobe Acrobat, Visio and excellent data entry skills.

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

December 21, 2011

Title:

Director, XenoLung Transplantation Logistics

Job Type:

Full-Time Position

Job Category:

Real Estate/Facilities

Location:

Silver Spring, MD

Experience Required:

Minimum five years previous experience in the field of human organ transplantation logistics.

Education Level:

Bachelor’s degree in Business, Supply Chain Management or other related field.

Role Purpose/Position Overview

Key Accountabilities/Responsibilities

• Create action plans to leverage strengths and achieve objectives (negotiating rates, terms or service).
• Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
• Administer standard operating procedures within the Transportation Department in accordance with Federal, state, and local regulations, including Board Policy and existing collective bargaining contracts.
• Develop and administer a transportation program to meet the requirements of the xenotransplantation program.
• Maintain all district-owned vehicular equipment and develops and implements a maintenance program for such equipment.
• Recommend procurement of materials, supplies and equipment for the Transportation Department through the Purchasing Department.
• Develop recommendations for new and replacement of vehicles based on existing and projected requirements.
• Recommend efficient transport routes and time schedules.
• Prepare and submit all reports pertaining to the Transportation Department including but not limited to worker’s compensation, vehicle accident and equipment inventory.
• Serve on the District Traffic Safety Committee and Pathways advisory committee.
• Review and monitor all requests for information from clients, government agencies, and other interested parties.

Requirements

• Minimum five years previous experience in the field of human organ transplantation logistics.
• Requires the ability to apply transportation logistics via ground and air
• Expert knowledge of local, national and international regions, trade, tariffs, customs and other regulations governing commerce and transportation.
• Experience in an international and domestic transportation/operational environment.
• Strong verbal and written communication skills, excellent troubleshooting and relationship-building skills.
• Ability to work effectively in a diverse, fast-paced team environment (with local and remote team members) and as individual.
• Ability to deal with various skill/ technical levels of business acumen.
• Strong decision-making and judgment skills, as well as excellent research, analytical and problem-solving skills.
• Ability to focus on goals and anticipate/ reduce risk.
• Expert knowledge of Business and Engineering Principles required. 

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

December 21, 2011

Title:

Flight Operations Specialist, XenoLung

Job Type:

Full-Time Position

Job Category:

Real Estate/Facilities

Location:

Silver Spring, MD

Experience Required:

Minimum of five years of experience in the field of human organ transplantation logistics

Education Level:

Bachelor’s degree in Engineering, Mathematics, Science or a closely related field is required.

Role Purpose/Position Overview

Key Accountabilities/Responsibilities

• Provide information on aircraft and/ or ground transport availability, weather projections, locations and time projections.
• Process cross-country and local flight clearances, including examination for conformance with flight rules and regulations.
• Outline available flight options and recommend course of action based on assessment of all relevant factors.
• Prepare and maintain cross-country kits.
• Draft flight plans and check accuracy.
• Coordinate flight plans with all related agencies.
• Maintain flight information on inbound and outbound flights.
• Monitor (with the proper agencies) overdue flights.
• Alert crash crew for emergencies.
• Safeguard classified material and maintain confidentially.
• Interpret and post teletype weather reports.
• Maintain individual flight records and functional files.
• Maintain flight operations equipment in a tactical environment.
• Prepare and submit operator’s meaconing, intrusion, jamming and interference reports.
• Maintain situation map. Reviews, consolidates, and prepares technical reports. Knows procedures for reporting flight violations. Prepares situation map. Supervises receipt and transfer of classified material. Participates in the development of a tactical crash rescue system.
• Maintain database of referrals and hospital locations; access, read and interpret county, state and specialized maps [for determining locations of accident scenes or referral sources].
• Provide statistical information as requested to include average flight distance, average time, latitudes and longitudes; provide directions for specific landing sites.
• Enter and record a variety of data and maintain a file of reports, forms, records and daily log.

Requirements

• Minimum of five years of experience in the field of human organ transplantation logistics
• Exert knowledge of terminology used in air navigation, awareness of air traffic control advisory radio procedures, Air Traffic Control procedures/ concepts and ability to process flight plan Information; encode, decode and post notices to airmen.
• Strong verbal and written communication skills, excellent troubleshooting and relationship-building skills.
• Ability to work effectively in a diverse, fast-paced team environment (with local and remote team members) and as individual.
• Ability to deal with various skill/ technical levels of business acumen.
• Strong decision-making and judgment skills, as well as excellent research, analytical and problem-solving skills.
• Ability to focus on goals and anticipate/ reduce risk.
• Must be able to obtain and maintain a U.S. Security Clearance at the appropriate level.
• Knowledge of engineering principles is required.
• Must have a passion for helping to cure end-stage lung disease by creating an unlimited supply of transplantable lungs sourced from miniature swine that are genetically modified, designated pathogen free (DPF) and part of a pre-treatment regimen that maximizes human tolerability with minimum immunosuppression.
• Ability to monitor, read and interpret weather radar information/ system, operate switchboard, two-way radio transmission and receiving console, mapping/ related systems and equipment in support of air medical and ground-based transport services.
• Ability to operate Apple and/ or PC; Advanced Microsoft Office Suite (2007 and 2010) skills: Word, Excel, Outlook, PowerPoint, Project required, as well as Adobe Acrobat and excellent data entry skills; experience with transportation tracking and planning software, such as CHAMP, EGOS, Sabre or Quintiq (with IATA CargoIMP messaging capability for seamless interface between Xeno Lung and customs authorities), NAS Computer System and/ or flight data communications systems is highly preferred.
• Experience with statistical analysis (software) and ability to synthesize data from various sources to identify trends required. 

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

December 09, 2011

Title:

Genetic Specialist, XenoLung

Job Type:

Full-Time Position

Job Category:

Research & Development

Location:

Silver Spring, MD

Experience Required:

Minimum ten years experience in genetic engineering and cloning.

Education Level:

Ph.D in Microbiology or related specialization

Role Purpose/Position Overview

The individual in this position will be responsible for managing the decision process with respect to xeongraft genetic modifications. 

Key Accountabilities/Responsibilities

Responsibilities include:

• Serves as a genetic counseling content expert; required passion for helping to cure end-stage lung disease by creating an unlimited supply of transplantable lungs sourced from miniature swine that are genetically modified, designated pathogen free (DPF) and part of a pre-treatment regimen that maximizes human tolerability with minimum immunosuppression.
• Coordinate the generation of disease-specific family history questionnaires [with other genetic counselors].
• Assess recurrence and occurrence of the condition, nature of the condition, mode of inheritance, recurrence risk, treatments, prognosis, available services and support groups.
• Collaborate closely with development team members to generate and test developed questionnaires.
• Evaluate and gather genetic risk assessment tools for monogenic and complex diseases particularly end-stage lung disease.
• Coordinates and supervises clinical aspects of the development, implementation, and validation of multiple disease family history and risk assessment tools.
• Collaborates with internal and external advisers to develop strategic goals for developing disease-specific modules.
• Collaborate on needs assessments with internal and external project personnel to adapt and modify modules for appropriate clinical use.
• Compilation of the quarterly progress form to report statistics to the Director of Preclinical Studies, the Preclinical Development team, key stake holders and upper-level management; the report will substantiate measures such as patients seen, evaluated, and tested.
• Collaborate with patient(s) medical doctor/ team to obtain and interpret specific data including family history, birth history, medical history and test results. Integrate clinic and genetic information for specialized laboratory and clinical testing.
• Prepare a written report of the patient’s clinic visit for the referring physician, agencies and families including recommendations and coordinate the implementation of those recommendations.
• Communicate with local physicians and families the timeliness of genetic evaluation for individuals. 
• This person will respond to inquiries from patients, physicians, nurses and community agencies regarding patient referrals and management.

Requirements

• Minimum ten years experience in genetic engineering and cloning.
• Strong verbal and written communication skills (allows one to obtain family histories and interpret these findings), excellent troubleshooting and relationship-building skills; ability to work with people and families in highly stressful and emotional situations. Ability to work with other professionals in a clinical setting.
• Ability to work effectively in a team environment with both local and remote team members, and as individual or with minimal supervision.
• Ability to deal with various skill/ technical levels of business acumen.
• Strong decision-making and judgment skills, as well as excellent research, analytical and problem-solving skills.
• Ability to focus on goals and anticipate/ reduce risk.
• Requires critical thinking, organizational skills, decisive judgment, analytical problem solving, communication, and good customer service skills.
• Expert knowledge of genetic principles.
• Experience with family history software is highly preferred.
• Experience with Waters Empower, Perkin Elmer Spectrum ES and SLIM software is highly preferred.
• Ability to operate Apple and/ or PC; Advanced Microsoft Office Suite (2007 and 2010) skills: Word, Excel, Outlook, PowerPoint, Project required, as well as Adobe Acrobat, Visio and excellent data entry skills.

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

December 21, 2011

Title:

Ground Operations Specialist, XenoLung

Job Type:

Full-Time Position

Job Category:

Research & Development

Location:

Silver Spring, MD

Experience Required:

Minimum of five years experience in the field of ground transport of biological products

Education Level:

Bachelor’s degree in closely related field is required.

Role Purpose/Position Overview

Key Accountabilities/Responsibilities

• Responsible for conducting and reviewing audits and maintenance of mass and balance documentation records.
• Review training material and loading systems to ensure they are up to date, reviewing the content of audits to ensure that they are fully compliant and all relevant subjects are covered. 
• Perform station visits and audits in accordance with duties and responsibilities.
•  Implement airfield and ground safety procedures to ensure a safe operating environment for personnel and patients.
• Relay departure, arrival, delay, aircraft/ vehicle and airfield/ ground status, and other pertinent information to uplinked controlling agencies.
• Procure, produce, and provide information on the safe operation of aircraft and other vehicles, such as flight planning publications, operations publications, charts/ maps, and weather information.
• Monitor the arrival, parking, refueling, loading, and departure of all aircraft and vehicles.
• Maintain air-to-ground and point-to-point radio contact with aircraft commanders.
• Plan and coordinate airfield construction/ modifications.
• Coordinate communications between air traffic control and maintenance personnel.
• Perform and supervise airfield management activities, including mobile airfield management functions.
• Maintain flight, ground transport and events logs, air crew flying records, and flight operations records (Flight Authorization forms) of incoming and outgoing flights.
• Receive, transmit, and control message traffic.
• Provide air and ground crews with information and services needed for airfield/ ground management and flight/ transport planning.
• Coordinate with agencies to meet aircrew requirements for billeting, messing, refueling, ground transportation, and transient aircraft maintenance.
• Receive and post weather information and flight plan data, such as air routes and arrival and departure times; also to conduct departure and arrival briefings.
• Coordinate changes to flight itineraries with appropriate Air Traffic Control (ATC) agencies.
• Anticipate, order and manage aircraft/ ground transport equipment and supply needs for evacuations and cargo flights/ shipments.
• Post visual display boards and status boards.
• Check military flight plans with civilian agencies.
• Use airfield landing and navigational aids and digital data terminal communications equipment to perform duties. 

Requirements

Minimum of five years experience in the field of ground transport of biological products as well as:

• Management experience and annual budget authority over $1 million
• Thorough understanding of transportation principles and methods for moving people or goods by air, rail, sea, or road, including the relative costs and benefits.
• Expert knowledge of public safety and security; aware of relevant equipment, policies, procedures, and strategies to promote effective local, state, or national security operations for the protection of people, data, property, and institutions.
• Comfortable and willingness to work directly with the public.
• Must be able to acquire and maintain a valid Security Identification Display Area (SIDA) Badge; also depending on location, must be able to acquire and maintain a United States Customs Clearance.
• Strong verbal and written communication skills, excellent troubleshooting and relationship-building skills.
• Ability to work effectively in a diverse, fast-paced team environment (with local and remote team members) and as individual.
• Ability to deal with various skill/ technical levels of business acumen.
• Strong decision-making and judgment skills, as well as excellent research, analytical and problem-solving skills.
• Ability to focus on goals and anticipate/ reduce risk.

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

December 21, 2011

Title:

Hematology Specialist, XenoLung

Job Type:

Full-Time Position

Job Category:

Clinical Operations

Location:

Silver Spring, MD

Experience Required:

Minimum of ten years experience in basic research related to organ, bone marrow, or stem cell transplantation.

Education Level:

PhD or MD required.

Role Purpose/Position Overview

Key Accountabilities/Responsibilities

• Manage scheduled and unscheduled maintenance to ensure acceptable instrument performance, writing and revising applicable operating procedures (OPs) with regard to testing processes.
• Complete scheduled and unscheduled review of quality control and equipment records, and managing testing for validation and research protocols following company and industry guidelines.
• Perform and interpret testing on product and donor samples (ensures daily instrument qualification was acceptable prior to reporting sample test results, perform granulocyte product qualification testing, perform donor sample testing as necessary, performs apheresis red cell, apheresis platelet and leukoreduced red cell product testing and research testing as directed.
• Manage and maintain quality control records to ensure acceptable instrument performance, establish and adjust quality control ranges, review, analyze and document review of quality control data, statistics and records, and manage and maintain instrument records to ensure acceptable instrument performance at least monthly.
• Investigate significant changes in quality control statistics and initiate appropriate action and report significant issues to the Director of Xeno Lung Science.
• Manage scheduled and unscheduled maintenance and troubleshooting procedures.
• Maintain adequate supplies of reagents, control materials and parts including lot acceptance procedures; review, analyze and document review of equipment data and records while investigating significant changes in equipment status and initiates appropriate action at least monthly.
• Serve as primary technical resource for department testing equipment issues.
• Ensure client result reporting is performed is a timely manner and any delays are clearly communicated.
• Manage and perform annual procedure evaluation and revision processes related to applicable testing procedures in a timely manner.
• Comply with departmental, company and regulatory and accrediting agency requirements and complete departmental processes in compliance with departmental policies and procedures.
• Manage and maintain storage of records including but not limited to sample test results, quality control data, instrument records and retained quality records. 

Requirements

• Minimum of ten years experience in basic research related to organ, bone marrow, or stem cell transplantation.
• Strong verbal and written communication skills, ability to obtain family histories and interpret the findings, excellent troubleshooting and relationship-building skills; ability to work with people and families in highly stressful and emotional situations. Ability to work with other professionals in a clinical setting.
• Ability to work effectively in a team environment with both local and remote team members, and as individual or with minimal supervision.
• Ability to deal with various skill/ technical levels of business acumen.
• Strong decision-making and judgment skills, as well as excellent research, analytical and problem-solving skills.
• Ability to focus on goals and anticipate/ reduce risk.
• Requires critical thinking, organizational skills, decisive judgment, analytical problem solving, communication, and good customer service skills.
• Expert knowledge of biological, genetic and medical principles is required.

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

December 21, 2011

Title:

Hospital Interface Specialist, XenoLung

Job Type:

Full-Time Position

Job Category:

Real Estate/Facilities

Location:

Silver Spring, MD

Experience Required:

Minimum of five years of experience in the field of billing, insurance and reimbursement for human organ transplantation expenses

Education Level:

Bachelor’s degree from an accredited institution in a Science or Health (e.g. Biology, Genetics, Nursing, Behavioral/ Social Science (Psychology/ Sociology,) or a combination of related fields is required. Master’s degree highly preferred.

Role Purpose/Position Overview

Key Accountabilities/Responsibilities

• Assist doctors, nurses and other hospital personal in selected patient care activities to be delegated after assessment by the professional discipline.
• Visit with patient and family regarding the benefits (including payers) and services of home health and what to expect at home. Assist in discharge planning, post referral, handling paperwork and making it easy to refer patients for Xeno Lung. Be visible and available to answer patient focused questions with case management and other clinicians.
• Register patients for services (obtain financial and demographic information).
• Provide explanation of benefits, obtains authorizations, and obtains required information based on District, State and Federal guidelines. Provide outstanding customer service in accordance with Unither Core Values.
• Focus on patient care and patient relationships; must effectively provide overall coordination of care for patients including education, regular outreach and engagement and empowerment of patients and families in their care, collaborating and facilitating management and communication with the patient/family, primary care provider team, specialists and other care resources.
• Ensure all care and activities are patient focused and individualized, resulting in personalized attention to each patient’s unique needs.
• Identify interventions and resources to assist the patient in reaching health related goals.
• Identify patterns and episodes of care that are predictive of future needs and services.
• Provide regular outreach and engagement to patients via visits, phone or e-mail.
• Integrate clinical and psychosocial information to identify patient care needs and conduct patient assessment to develop action-oriented and time specific planning and implementation of appropriate interventions.
• Integrate and coordinate the expertise and support of other health professionals, family members, and health care providers across the care continuum.
• Adheres to policies and procedures in daily activities.
• Coach and assist patient with goal setting to assist in behavioral change.
• Provide effective patient education to assist patients/families in ongoing care management.
• Facilitate care through the use of registries, information technology, health information exchange and other means to assure that patients get the indicated care when and where they need and want it in a culturally and linguistically appropriate manner.
• Advocate for patients to support the attainment of optimal, patient-centered outcomes that are defined by a care planning process driven by a partnership between providers, hospital, care teams, patients and patient’s family.
• Maintain confidentiality of information in accordance with organization policy.
• Document all encounters according to organization policy and procedure.
• Ability to understand and prepare patient focused written materials to educate and inform referral sources and the community.

Requirements

• Minimum of five years experience in:
  • Field of billing, insurance and reimbursement for human organ transplantation expenses
  • Nursing in an acute care or ambulatory care setting with current clinical knowledge as it relates to chronic disease management required.
• Experience assessing, educating and providing self-care management support to patients/families while coordinating with hospital personnel.
• Requires knowledge of care appropriate to the age and developmental level of the patients served and procedures and standards related to patient care activities.
• Expert knowledge of medical and infection control principles.
• Previous experience in medical office setting preferred.
• Nursing background requires current RN or LPN license in Maryland.
• Crisis Prevention Institute (CPI) certification highly preferred.
• Participation in ongoing independent study and education-related professional activities to maintain and increase knowledge in the areas of care management and patient services for development of effective care coordination skills required.
• Insurance benefit soft ware and medical terminology experience required.
• Experience in data analysis and family history software systems highly preferred.
• Ability to operate Apple and/ or PC; Advanced Microsoft Office Suite (2007 and 2010) skills: Word, Excel, Outlook, PowerPoint, Project required, as well as Adobe Acrobat, Visio and excellent data entry skills. 

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

December 21, 2011

Title:

Immunology Specialist, XenoLung

Job Type:

Full-Time Position

Job Category:

Clinical Operations

Location:

Silver Spring, MD

Experience Required:

Minimum ten years of experience in basic research related to organ, bone marrow, or stem cell transplantation.

Education Level:

Ph.D or MD required.

Role Purpose/Position Overview

Key Accountabilities/Responsibilities

• Analyze laboratory findings to check the accuracy of the results.
• Set up, clean, and maintain laboratory equipment.
• Enter data from analysis of medical tests or clinical results into computer for storage.
• Operate, calibrate, and maintain equipment used in quantitative or qualitative analysis, such as spectrophotometers, calorimeters, flame photometers, or computer-controlled analyzers.
• Establish and monitor quality assurance programs or activities to ensure the accuracy of laboratory results.
• Conduct chemical analysis from lung and chest cavity samples as well as body fluids, including blood, urine, or spinal fluid, to determine presence of normal or abnormal components.
• Develop, standardize, evaluate, and modify procedures, techniques, or tests used in the analysis of specimens or in medical laboratory experiments.
• Collect and study lung, body cavity and blood samples to determine the number of cells, their morphology, or their blood group, blood type, or compatibility for transfusion purposes, using microscopic techniques.
• Analyze samples of biological material for chemical content or reaction.
• Obtain, cut, stain, and mount biological material on slides for microscopic study and diagnosis, following standard laboratory procedures.
• Cultivate, isolate, or assist in identifying microbial organisms or perform various tests on these microorganisms.
• Select and prepare specimens and media for cell cultures, using aseptic technique and knowledge of medium components and cell requirements.
• Conduct medical research under direction of microbiologist or biochemist.
• Harvest cell cultures at optimum time, based on knowledge of cell cycle differences and culture conditions.
• Must have a passion for helping to cure end-stage lung disease by creating an unlimited supply of transplantable lungs sourced from miniature swine that are genetically modified, designated pathogen free (DPF) and part of a pre-treatment regimen that maximizes human tolerability with minimum immunosuppression.

Requirements

• Minimum ten years of experience in basic research related to organ, bone marrow, or stem cell transplantation.
• Strong verbal and written communication skills, ability to obtain family histories and interpret the findings, excellent troubleshooting and relationship-building skills; ability to work with people and families in highly stressful and emotional situations. Ability to work with other professionals in a clinical setting.
• Ability to work effectively in a team environment with both local and remote team members, and as individual or with minimal supervision.
• Ability to deal with various skill/ technical levels of business acumen.
• Strong decision-making and judgment skills, as well as excellent research, analytical and problem-solving skills.
• Ability to focus on goals and anticipate/ reduce risk.
• Requires critical thinking, organizational skills, decisive judgment, analytical problem solving, communication, and good customer service skills.
• Expert knowledge of biological, chemical, and medical principles (knowledge of the following: plant and animal organisms, their tissues, cells, functions, interdependencies, and interactions with each other and the environment; chemical composition, structure, and properties of substances and of the chemical processes and transformations that they undergo. This includes uses of chemicals and their interactions, danger signs, production techniques, and disposal methods; information and techniques needed to diagnose and treat human injuries, diseases, and deformities. This includes symptoms, treatment alternatives, drug properties and interactions, and preventive health-care measures).

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

December 21, 2011

Title:

International Regulations Specialist, XenoLung

Job Type:

Full-Time Position

Job Category:

Regulatory

Location:

Silver Spring, MD

Experience Required:

Minimum five years previous experience within the sFDA or in an sFDA regulated company with responsibility for biological approvals.

Education Level:

Bachelor’s of Science and Law degree

Role Purpose/Position Overview

Key Accountabilities/Responsibilities

• Draft guidelines for advanced donor screening and more organ testing to help protect patients from infections transmitted through transplants.
• Provide general and technical regulatory input to local or international product (development) teams and other Xeno Lung departments as appropriate; participate on various global project teams as core team member.
• Provide final submissions and associated documentation to Xeno Lung operating units and/or regulatory agencies.
• Perform quality audits/ write improvement plans, reliability engineering, fault analysis and troubleshooting, corrective action tracking and quality management training.
• Acquire required documentation for any type of submission which may include labeling, R&D reports, import documents or international submissions; communicate and give guidance to other departments regarding report format and timeline expectations.
• Manage complaint handling, reporting/ vigilance reporting, field actions, and label control.
• Development of clinical investigation plans, Case Report Forms and conduct of monitoring in compliance with GCP’s and ISO, CE FDA, etc. regulations.
• Ensure the proper processes, policies and procedures are in place to obtain necessary regulatory approvals and maintain regulatory compliance.
• Develop strategies for drug and medical device submissions to regulatory agencies; ability to understand and interpret US and international drug and medical device and transplantation regulatory requirements; monitor external regulatory developments, identify risks and provide risk assessments and regulatory options, and communicate all potential issues to senior management.
• Collaborate with other industry professionals and companies in order to prepare, acquire and maintain Asia/ Pacific, Mexican and Canadian and other international entities (as deemed applicable) regulatory dossiers and licenses.
• Assure all regulatory submissions are accurate and submitted in a timely manner and determine if regulatory submissions are required or if a memo-to-file is adequate.
• Assure all marketing, sales and other materials (e.g. labels) and practices are in conformance with regulatory requirements.
• Development and execution of clinical investigation training for investigators, site personnel, and internal Xeno Lung clinical applications support personnel in compliance with good clinical practices.
• Assure compliance with all related regulations governing conduct of clinical investigations including financial disclosure.
• Administration of ongoing relationships with Institutional Review Boards, Ethics Committees, and country competent authorities including ongoing reporting obligations for continuing studies, FDA clinical trials registry requirements, and other applicable regulations.
• Assist in the planning and budgeting for clinical investigations supportive to product development objectives.
• Coordinate inspection of the organization and contract facilities, and develops procedures to ensure regulatory compliance.
• Generate reports, utilizing statistics, as appropriate, to evaluate trends and to aid management in the identification and resolution of issues and overall quality improvement effort.  Recommend KPI’s to measure compliance with quality standards and effectiveness of corrective actions across all functions.
• Assure control and proper disposition of nonconforming products and corrective actions.
• Maintain Corrective & Preventive Action (CAPA) process and ensure timely follow-up, and implementation of corrective actions.
• Conduct Quality System Audits and assure corrective action is performed.Assume responsibility for management of regulatory submissions and coordinating drafting, editing, and preparation of regulatory submissions (including routine correspondence, INDs, BLAs, NDAs, DMFs, Annual Reports, Amendments, Supplements, Orphan Drug Applications, etc.)

Requirements

• Minimum five years previous experience within the sFDA or in an sFDA regulated company with responsibility for biological approvals.
• Prior 510(k) and/or drug submission and PMA/NDA authoring experience preferred.
• Maintain a working knowledge of published regulations and any changes for all local and international regulatory agencies; will require continuous education (e.g. attending seminars/ classes, certification/ recertification).
• Strong communication skills - able to challenge, influence, and articulate a view and drive behavior or action and train employees.
• Self-starter who works with a sense of urgency and acts as a good team player working with other disciplines.
• Requires working knowledge of medical and/ or veterinary medical and biology principles.
• Ability to translate documents and/ or experience working with Language Translation vendors a plus.
• Must be eligible to work in the U.S. without restriction and able to acquire clearance for the National Agency Check and Inquiries (NACI).
• Extensive knowledge of: FDA (including GMP and (particularly the safety, purity, potency, and effectiveness of biological products including vaccines, blood and blood products, and cells, tissues, and gene therapies for the prevention, diagnosis, and treatment of human diseases, conditions, or injury, and methods used to defend the public against the threats of emerging infectious diseases and bioterrorism and organ transplantation), experience prioritizing patient safety, recommendations to reduce unintended disease in organ recipients; CE, and ISO strongly preferred.
• Experience with medical devices; Implant and transplant experience preferred, as well as knowledge of engineering principles.
• A proven ability to deliver value in the following areas: supplier quality audits/improvement plans, reliability engineering, fault analysis and troubleshooting, corrective action tracking and quality management training.
• Strong track record of collaborative working relationship with itnernatonal government agencies including the FDA, ISO, etc; FDA and EU on-site audit experience preferred.
• Ability to manage and report on projects and drive them to conclusion.
• A passion for helping to cure end-stage lung disease by creating an unlimited supply of transplantable lungs sourced from miniature swine that are genetically modified, designated pathogen free (DPF) and part of a pre-treatment regimen that maximizes human tolerability with minimum immunosuppression. 

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

December 02, 2011

Title:

Lung Disease Specialist (End Stage), XenoLung

Job Type:

Full-Time Position

Job Category:

Research & Development

Location:

Silver Spring, MD

Experience Required:

Minimum 10 years experience in treating or managing end-stage lung disease patients.

Education Level:

Ph.D or MD in Pulmonary Medicine

Role Purpose/Position Overview

The individual in this position will have primary responsibility for helping to shape Key Opinion Leader views with regard to participation in a xenotransplantation clinical development program related to end-stage lung disease.

Key Accountabilities/Responsibilities

Responsibilities include:

• Analyze patient evaluation, perform diagnostic tests and treat/ monitor end-stage lung disease.
• Work with Thoracic Surgeons and other specialists and medical professionals to manage operative procedures and oversee postoperative care; includes reviewing medical histories, assessing patients, biochemical tests, tissue biopsy, cardiac catheterization and electrocardiography, etc.
• Treat patients with a respirator or CPR or suggest surgery in traumatic situations, including single- and double-lung transplants.
• Create pre-transplant evaluation, candidate qualifying and post-transplant care programs for patients 

Requirements

• Minimum 10 years experience in treating or managing end-stage lung disease patients.
• Ph. D. In Pulmonary Medicine.
• Thorough knowledge of internal medicine and other specialties.
• Knowledge and relationships with key opinion leaders in field of pulmonology.
• Experience in handling occupational medicine and respiratory therapy departments and intensive care units.
• Ability to work well under intense pressure and emotional stress is important. Consequently, must be emotionally stable, patient and sympathetic with patients.
• Ability to communicate and work with individuals across all functional areas and departments.
• Strong oral communication, interpersonal and leadership skills are key.
• Must be able to research and analyze complex symptoms, diseases and behaviors.
• Experienced use of typical medical equipment including but not limited to a stethoscope, a bronchoscope and a spirometer.
• Ability an expert knowledge of specialized procedures such as taking samples from the lungs or from the lining of the chest as well as perform a variety tests. 

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

September 15, 2011

Title:

Manager, Regulatory Affairs

Job Type:

Full-Time Position

Job Category:

Regulatory

Location:

Silver Spring, MD

Experience Required:

6-10 years direct regulatory experience in pharmaceutical/biotech industry

Education Level:

Bachelor’s Degree

Role Purpose/Position Overview

Key Accountabilities/Responsibilities

The candidate for this position should be prepared to:

• Serve as the primary contact for the communication with the European regulatory agencies and vendors in regard to the preparation and the submission of CTA’s, MAA, the Scientific Advice, variations, PSUR and Orphan Drug documentation.
• Work closely with project teams to ensure that all activities are conducted in compliance with relevant laws, regulations, and guidance.
• Assemble, review and file country specific regulatory submissions and assists in the management of regulatory files.
• Ensure submissions are complete, properly formatted, and comply with applicable regulatory requirements.
• Excellent oral and written communication skills, including the ability to discuss scientific /technical data and regulatory requirements with senior management and regulatory agency personnel.
• Perform regulatory research to assist in formulation of regulatory strategic decisions.
• Assist in the development of global standards and regulatory SOPs.
• Work effectivly within a team-oriented, international business culture and demonstrate escellent planning and organizational skills in a multidisciplinary enviornment

• In conjunction with the Director of Regulatory Affairs, will create and execute regulatory development plans.
• Perform regulatory research to assist in formulation of regulatory strategic decisions.
• Assist in the development of global standards and regulatory SOPs.

• All other duties as assigned

Requirements

• Bachelor’s degree in life sciences
• Prefer Regulatory Affairs Certification (RAC EU)
• 6-10 years direct regulatory experience in pharmaceutical/biotech industry
• A blend of CMC and clinical regulatory experience preferred
• Direct experience with GMP QA is preferred
• MS Office suite of programs, advanced knowledge of MS word
• Prefer experience with electronic publishing tools and electronic document management systems.
• MS Office suite of programs, advanced knowledge of MS word
• Prefer experience with electronic publishing tools and electronic document management systems
• Occasional travel

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

December 09, 2011

Title:

NHP Studies Specialist, XenoLung

Job Type:

Full-Time Position

Job Category:

Research & Development

Location:

Silver Spring, MD

Experience Required:

Minimum ten years of medical experience testing biologics in baboons

Education Level:

Ph.D in Zoology or other field relate to knowledge of baboon physiology and molecular biology.

Role Purpose/Position Overview

The individual in this position will manage key aspects of the process of testing genetically modified xenografts in baboons. 

Key Accountabilities/Responsibilities

Responsibilities include:

• Follow set procedures as dictated by federal regulations governing laboratory animals.
• Conduct physical examinations, administer medications and treatments; diagnose health problems, review medical history records; conduct physical examinations and treatments; clean and suture wounds; calculate appropriate drug doses; perform routine diagnostic lab tests; report laboratory test results to appropriate parties; maintain the cleanliness and orderliness of the animal care facility.
• Provide and/or oversee laboratory, research, or animal care support for animals, such as feeding and grooming.
• Conduct routine tests, compile data and maintain quality control, collect and prepare samples.
• Responsible for total functions of laboratory units, research projects, writing research papers as author or co-author, generate reports, research literature related to project/procedures, provide input and/ or write segments of reports and manuscripts.
• Receive, distribute and prepare packages, samples and supplies.
• Prepare sample test kits and media.
• Report laboratory, autopsy and necropsy procedures impact outcomes of tests and research, and impact the safety, health, and well-being of laboratory animals.
• Analysis and compilation of data, communicate findings/research results, maintain equipment and order supplies. 

Requirements

• Minimum ten years of medical experience testing biologics in baboons.
• Strong verbal and written communication skills (allows one to obtain family histories and interpret these findings), excellent troubleshooting and relationship-building skills; ability to work with people and families in highly stressful and emotional situations. Ability to work with other professionals in a clinical setting.
• Ability to work effectively in a team environment with both local and remote team members, and as individual or with minimal supervision.
• Ability to deal with various skill/ technical levels of business acumen.
• Strong decision-making and judgment skills, as well as excellent research, analytical and problem-solving skills.
• Ability to focus on goals and anticipate/ reduce risk.
• Requires critical thinking, organizational skills, decisive judgment, analytical problem solving, communication, and good customer service skills.
• Expert knowledge of genetic principles.
• Experience with family history software is highly preferred.
• Experience with Waters Empower, Perkin Elmer Spectrum ES and SLIM software is highly preferred.
• Ability to operate Apple and/ or PC; Advanced Microsoft Office Suite (2007 and 2010) skills: Word, Excel, Outlook, PowerPoint, Project required, as well as Adobe Acrobat, Visio and excellent data entry skills .

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

December 02, 2011

Title:

Pre-treatment Specialist, XenoLung

Job Type:

Full-Time Position

Job Category:

Clinical Operations

Location:

Silver Spring, MD

Experience Required:

Minimum ten years experience in pre-treatment protocols related to organ, bone marrow or stem cell transplantation

Education Level:

Ph.D or MD in related scientific field(s)

Role Purpose/Position Overview

The individual in this position will be responsible for managing transplantation animal donor and recipient pre-treatment protocols with the goal of successful development of xenografts for end-stage organ disease.

Key Accountabilities/Responsibilities

Responsibilities include:

• Develop and record new protocols, modification and continuing review information for prospective and retrospective clinical research protocols in protocol management database.
• Maintenance of prospective and retrospective clinical research protocols.
• Prepare submissions for institutional review board and/or scientific review board approval of investigator-initiated new studies and amendments
• Maintains all current and historical information on Xeno Lung's clinical pre-treatment research protocols in the protocol management database and DocuShare document sharing system.
• Serve as a database administrator for the protocol management database.
• Coordinate language translation of informed consent documents for research participants.
• Assist with the dispensation and receipt of study related information (e.g., test samples, regulatory documents, etc.). Participates in data retrieval, reporting, and preparation of files for various studies.

Requirements

• Minimum ten years experience in pre-treatment protocols related to organ, bone marrow or stem cell transplantation.
• Experience managing a team of at least five scientists and two laboratories.  
• Strong verbal and written communication skills, ability to obtain family histories and interpret the findings, excellent troubleshooting and relationship-building skills; ability to work with people and families in highly stressful and emotional situations. Ability to work with other professionals in a clinical setting.
• Ability to work effectively in a team environment with both local and remote team members, and as individual or with minimal supervision.
• Ability to deal with various skill/ technical levels of business acumen.
• Strong decision-making and judgment skills, as well as excellent research, analytical and problem-solving skills.
• Ability to focus on goals and anticipate/ reduce risk.
• Requires critical thinking, organizational skills, decisive judgment, analytical problem solving, communication, and good customer service skills.
• Expert knowledge of biological, genetic and medical principles as well as social is required.
• Experience with family history software is highly preferred.
• Experience with Waters Empower, Perkin Elmer Spectrum ES and SLIM software is highly preferred.
• Ability to operate Apple and/ or PC; Advanced Microsoft Office Suite (2007 and 2010) skills: Word, Excel, Outlook, PowerPoint, Project required, as well as Adobe Acrobat, Visio and excellent data entry skills.

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

December 02, 2011

Title:

Program Management Specialist, XenoLung

Job Type:

Full-Time Position

Job Category:

Research & Development

Location:

Silver Spring, MD

Experience Required:

Ten years experience managing complex biological pharamaceutical projects

Education Level:

Ph.D or equivalent in life sciences field

Role Purpose/Position Overview

The individual in this position will provide program management support to deliver projects within the established budget and time line, as well as participate in program and project development, including the dissemination of project information. 

Key Accountabilities/Responsibilities

Responsibilities include:

• Assist with the implementation of programs and projects.
• Planning, developing, implementing and evaluating programs and projects.
• Coordinating project activities, collaborating with project team members, developing measurable project goals and objectives and monitoring progress toward achievement.
• Prepare/ facilitate meetings, meeting agendas, and document key decisions and collaborate with team members to develop project collateral.
• Write and disseminate work plans and project documents, including procedures, proposals, progress reports and presentations.

Requirements

• Ten years experience managing complex biological pharamaceutical projects
• Plan, manage and deliver successful programs and projects.
• Knowledge of information technology management, systems administration, training, software development, contract management and proposal development, budgeting, financial management, project management and business research are a plus.
• Experienced in data analysis; SharePoint, Oracle, SAP RPM, and/ or NetPoint a plus.
• Ability to operate Apple and/ or PC; Advanced Microsoft Office Suite (2007 and 2010) skills: Word, Excel, Outlook, PowerPoint, Project required, as well as Adobe Acrobat, Visio and excellent data entry skills.

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

December 02, 2011

Title:

Protocol Development Specialist, XenoLung

Job Type:

Full-Time Position

Job Category:

Clinical Operations

Location:

Silver Spring, MD

Experience Required:

Minimum ten years experience as key member of a team that obtained regulatory approval of a novel transplantation-related therapeutic

Education Level:

Ph.D or equivalent degree in a transplantation medicine specialty

Role Purpose/Position Overview

The individual in this position will document, development, submit, file and report clinical trial protocols to institutional, state, federal and international regulatory agencies to achieve and maintain compliance with internal policy and external sponsor and federal/ international regulations related to United Therapeutics’ xenotransplantation program. 

Key Accountabilities/Responsibilities

Responsibilities include:

• Maintenance of prospective and retrospective clinical research protocols.
• Develop and record new protocols, modification and continuing review information for prospective and retrospective clinical research protocols in protocol management database.
• Ensure Institutional Review Board (IRB) approved protocols and consents are properly updated in and submitted to the protocol management database.
• IRB processing and regulatory document gathering and submissions.
• Prepare submissions for institutional review board and/or scientific review board approval of investigator-initiated new studies and amendments.
• Maintains all current and historical information on Xeno Lung's clinical research protocols in the protocol management database and DocuShare document sharing system.
• Serve as a database administrator for the protocol management database.
• Coordinate language translation of informed consent documents for research participants.
• Assist with the dispensation and receipt of study related information (e.g., test samples, regulatory documents, etc.). Participates in data retrieval, reporting, and preparation of files for various studies.
• Perform quality assurance functions for the protocol management database and DocuShare databases. 

Requirements

• Minimum ten years experience as key member of a team that obtained regulatory approval of a novel transplantation-related therapeutic.
• Experience in development of clinical trials protocols, ideally end-stage lung disease.
• Expert knowledge of research methodologies, institutional, state, federal and international regulatory guidelines, Good Clinical Practices (GCP’s) and of the Code of Regulations.
• Experience in research data management, medical and/or scientific field is required.
• Strong verbal and written communication skills (allows one to obtain family histories and interpret these findings), excellent troubleshooting and relationship-building skills; ability to work with people and families in highly stressful and emotional situations. Ability to work with other professionals in a clinical setting.
• Ability to work effectively in a team environment with both local and remote team members, and as individual or with minimal supervision.
• Ability to deal with various skill/ technical levels of business acumen.
• Strong decision-making and judgment skills, as well as excellent research, analytical and problem-solving skills.
• Ability to focus on goals and anticipate/ reduce risk.
• Requires critical thinking, organizational skills, decisive judgment, analytical problem solving, communication, and good customer service skills. 
• Experience using clinical trials management software such as DocuShare, OnCore or Velos to develop protocol calendars, CRF development, and document tracking and sharing.
• Experience using search engines and writing literature reviews; proficiency with bibliography management software such as EndNote, Papyrus or Reference Manager.
• Ability to operate Apple and/ or PC; Advanced Microsoft Office Suite (2007 and 2010) skills: Word, Excel, Outlook, PowerPoint, Project required, as well as Adobe Acrobat, Visio, Wisdom and excellent data entry skills. 

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

September 21, 2011

Title:

Senior Clinical Research Associate

Job Type:

Full-Time Position

Job Category:

Clinical Operations

Location:

Silver Spring, MD

Experience Required:

4-7 years experience in planning and overseeing pharmaceutical clinical trials

Education Level:

BA/BS degree in nursing, pharmacy, life scineces or health related discipline

Role Purpose/Position Overview

The SR CRA will have in-depth experience in the planning, initiation, management, and close-out of clinical trials.

Essential functions include and are not limited to the following:

• Ability to resolve and make judgements regarding administrative, scientific and/or clinical problems under general supervision.
• Assist in the design, planning and implementation of clinical research projects, including drafting project plans and timelines as needed.
• Identify and establish the suitability of study investigators and their investigative sites, and to liaise with them to ensure compliance with all necessary study requirements, approvals and agreements (e.g. financial; confidentiality; indemnity).
• Initiate, train, monitor and close out investigational study sites and their staff in accordance with company SOPs, GCP and all relevant regulatory requirements.
• Establish and maintain a close working relationship with all internal and external (e.g. contractor) clinical research personnel and relevant functional support groups (e.g. data management, regulatory affairs, etc.) across the business. 
• Ensure that sites have adequate study supplies in accordance with the relevant study protocol requirements and company SOPs.
• Ensure the appropriate tracking, storage and disposition of returned clinical study supplies.
• Prepare for, facilitate and act on the audit of study documentation, including investigator, pharmacy, laboratory and sponsor study files.
• Ensure the timely reporting of all serious adverse events to the Global Drug Safety department, and the appropriate follow-up, in accordance with company SOPs.
• Assist with generation and review of clinical study documentation as required and ensure that it is distributed and filed in accordance with regulatory guidelines and company SOPs.
• Develop a detailed knowledge of all relevant ICH GCP, ethical and regulatory guidelines and legal requirements for the conduct of clinical research.
• Develop technical expertise and scientific knowledge by maintaining an up-to-date awareness of relevant scientific literature and by attending and participating in appropriate external scientific meetings.
• Assist in the preparation and completion of IND, BLA, and NDA documents, as well as product annual reports.
• May assist in updating of the Investigator’s Brochure and final study reports for assigned protocols.
• Review, revise develop SOPs.
• Review data listings on an ongoing basis.
• Ability to indirectly supervise subordinate staff personnel.
• Provide clinical and technical support for CRA I/II and administrative staff.
• Plan coordinating Investigator Meetings.
• Undertake any other tasks appropriate to this position as directed by clinical line manager of Lung LLC.

Key Accountabilities/Responsibilities

• The Senior CRA reports to the Manager of Clinical Monitoring Department US. This position has no line management responsibilities.
• Will develop close working relationship with all Lung LLC and external (contractor) clinical development personnel.  Will also interface with all groups associated with clinical drug development at Lung LLC including regulatory affairs, data management, drug safety etc.
• Represent company in a professional manner; establish and maintain good relationships with investigators and study site personnel.
• Position requires superior verbal and written communication skills as needed, for interactions with vendors (i.e. central laboratories, interactive voice response service for randomization (IVRS), etc), research physicians and associated hospital organizations
• Position requires ongoing maintenance of budgets and costs associated with clinical trial investigator sites and other contractors, as appropriate.

Requirements

• Bachelor Degree in Science, Nursing or equivalent clinical degree is required
• ACRP or other GCP related certifications is preferred.
• Excellent communication skills required including a good overall scientific vocabulary.
• Fluency in at least one additional foreign language would be an advantage (e.g. French, German, Italian, Spanish).
• Competent end user of Microsoft Office software suite including Word / Excel / Outlook / PowerPoint.
• Ability to travel 50-75%. May fluctuate up or down relative to the status of a given project.
• Able to physically carry basic materials to maintain proficiency and accessibility during travel. Including but not limited to a laptop computer, small amounts of files, personal luggage, etc.
• Ability to meet the physical demands of travel.

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

January 16, 2012

Title:

Senior Director of Sales

Job Type:

Full-Time Position

Job Category:

Sales & Marketing

Location:

Silver Spring, MD

Experience Required:

12+ years

Education Level:

Minimum BA/BS Degree

Role Purpose/Position Overview

• Attain sales and tactical plan objectives for Lung, LLC.
• Direct and manage all critical sales, customer relations, and reporting functions in order to achieve optimal results.
• Analyze overall sales force effectiveness and develop solutions that will improve performance and resource utilization.
• Coordinate with S&M management peers, cross-functional team members, and UT colleagues to optimize brand and launch strategies.
• Represent Lung, LLC to external clients and serve as a role model for senior management to subordinates/managers/partners. 
• Act as a resource for the head of Sales and Marketing in areas of sales planning and data interpretation.
• Apply in-depth knowledge of and experience in pharmaceutical industry, sales strategies and tactics, performance management, drug distribution and managed care.
• Maintain focus in a fast-paced and dynamic environment which includes managing the complexities of partnerships.

Key Accountabilities/Responsibilities

• Achieve area sales and expense management goals.
• Ensure deployment and development of highly effective, skilled, cohesive, and motivated sales management and sales teams.
• Effectively analyze sales and market data to identify opportunities and areas of concern
• Strategically allocate area sales effort and resources based on physician and account priority ensuring alignment with UT sales teams. 
• Manage KOLs and "key accounts" in assigned area
• Complete training and regular field visits with Region Business Directors and Pulmonary Specialists. Effectively coach members of the sales team.
• Conduct regular sales meetings focused on sales progress, competitive issues, opportunities, and training.
• Make periodic presentations to senior management regarding sales trends, market characteristics and resource needs.
• Address performance management issues effectively, engaging HR, supervisor, etc. as needed in order to avoid legal issues.
• Assist in the development of sales goals, training programs, incentive plan design and sales force alignment, among other strategic sales initiatives.
• Manage 4-6 Region Business Directors.

Abide by Company policies and government laws and regulations. Ensure training of the sales force avoiding Legal and ethical issues

Requirements

• Minimum of twelve or more years experience in the pharmaceutical industry is required with at least six years of sales and marketing management experience.  Experience in the corporate setting in other functional areas such as Marketing, Healthcare Relations, Sales Operations, and/or Sales Training is highly desirable.   Knowledge of cardiology and/or pulmonary markets and expertise in managing partnerships are critical. 
• Track record of developing people for higher levels of responsibility is necessary.
• Experience in managing teams of people including cross-functional team management. 
• Ability to delegate and get things done through others is a prerequisite.
• Ability to travel 50-65% of time.
• A minimum of a BA/BS degree is required.  
• In-depth knowledge of the pharmaceutical industry, strategy development, sales force management, sales force expansion, and tactical implementation are necessary. 

Must have confidence in interacting with physicians, vendors, and competitors within the pharmaceutical and biotechnology market. 

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

December 02, 2011

Title:

Toxicology Specialist, XenoLung

Job Type:

Full-Time Position

Job Category:

Research & Development

Location:

Silver Spring, MD

Experience Required:

Minimum ten years previous experience in pre-clinical toxicology, preferably with a biologic drug

Education Level:

Ph.D in Pharmacology, Biochemsitry or equivalent.

Role Purpose/Position Overview

The individual in this position will be responsible for analyzing and presenting research findings of the toxicological effects of xenografts in animal models to the Director of Preclinical Studies, the Preclinical Development team, the Xeno Lung organization, upper-level management and key stake holders.

Key Accountabilities/Responsibilities

Responsibilities include:

• Designs and oversees regulatory and investigative toxicology studies of xenografts in animal models
• Analyze and evaluate statistical data and researching scientific literature.
• Study the harmful effects of external agents like chemicals, toxicologists find possible ways to reduce the risk of these threats.
• To develop reports in order to highlight the risk analysis of toxicity in the environment and submit the reports with highlights on safety measures that are required to curb the problem; using experimental data to assess a drug's toxicity and create a safety profile, and balancing potential benefits against any risks.
• Tracks and monitors existing and pending legislation/regulations and serves as arepresentative on external trade and scientific associations.

Requirements

•  Minimum ten years previous experience in pre-clinical toxicology, preferably with a biologic drug.
• Experienced in data analysis.
• Experience with Waters Empower, Perkin Elmer Spectrum ES and SLIM software is highly preferred.
• Strong verbal and written communication skills (allows one to obtain family histories and interpret these findings), excellent troubleshooting and relationship-building skills; ability to work with people and families in highly stressful and emotional situations. Ability to work with other professionals in a clinical setting.
• Ability to work effectively in a team environment with both local and remote team members, and as individual or with minimal supervision.
• Ability to deal with various skill/ technical levels of business acumen.
• Strong decision-making and judgment skills, as well as excellent research, analytical and problem-solving skills.
• Ability to focus on goals and anticipate/ reduce risk.
• Requires critical thinking, organizational skills, decisive judgment, analytical problem solving, communication, and good customer service skills.
• Expert knowledge of genetic principles.

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

January 16, 2012

Title:

Pulmonary Specialist, Indianapolis

Job Type:

Full-Time Position

Job Category:

Sales & Marketing

Location:

Home office – US

Experience Required:

8-12 years experience within the specialty pharmaceutical or biotech market place successfully selling to specialized physicians, nurses and other healthcare professionals (i.e.; cardiologists, pulmonologists, etc)

Education Level:

Bachelor Degree in Science, Nursing or equivalent clinical degree is required

Role Purpose/Position Overview

Lung LLC is a fully owned subsidiary of United Therapeutics Corporation, a publicly traded biotechnology company focused on the development and commercialization of innovative therapeutic products for patients with chronic diseases.  We are seeking a Pulmonary Specialist (PS) – for the Indianapolis territory.  The PS will be solely responsible for growing market share and increasing sales of Adcirca within a defined territory of targeted physicians and key accounts through effective territory management and execution of sales/marketing strategies.  The PS will be an active resource for all customers involved in the treatment of PAH, including patients (as appropriate).  This includes providing information relating to Adcirca according to package inserts.

Key Accountabilities/Responsibilities

• Educate and sell health care professionals on marketed products.
• Build strategic relationships with KOLs, influences, and accounts.
• Represent Lung LLC at local, regional and national conferences and symposia.
• Responsible for an assigned geographic territory and designated accounts to actively interface with the PAH community.
• Expand the awareness of Lung LLC and our Company’s focus and commitment in the research, development & commercialization of products for pulmonary diseases.

Requirements

• Bachelor Degree in Science, Nursing or equivalent clinical degree is required
• 8-12 years experience within the specialty pharmaceutical or biotech market place successfully selling to specialized physicians, nurses and other healthcare professionals (i.e.; cardiologists, pulmonologists, etc)
• 2-3 years experience selling within the institutional or major teaching centers environments is required
• Expertise in the cardiovascular and/or pulmonary disease therapeutic areas is preferred
• Experience in working with professional community advocacy organizations is helpful
• Position requires 25-50% travel, but the amount is territory specific.

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

December 01, 2011

Title:

Pulmonary Specialist, San Antonio

Job Type:

Full-Time Position

Job Category:

Sales & Marketing

Location:

Home office – US

Experience Required:

8-12 years experience within the specialty pharmaceutical or biotech market place successfully selling to specialized physicians, nurses and other healthcare professionals (i.e.; cardiologists, pulmonologists, etc)

Education Level:

Bachelor Degree in Science, Nursing or equivalent clinical degree is required

Role Purpose/Position Overview

Lung LLC is a fully owned subsidiary of United Therapeutics Corporation, a publicly traded biotechnology company focused on the development and commercialization of innovative therapeutic products for patients with chronic diseases.  We are seeking a Pulmonary Specialist (PS) – for the San Antonio territory.  The PS will be solely responsible for growing market share and increasing sales of Adcirca within a defined territory of targeted physicians and key accounts through effective territory management and execution of sales/marketing strategies.  The PS will be an active resource for all customers involved in the treatment of PAH, including patients (as appropriate).  This includes providing information relating to Adcirca according to package inserts.

Key Accountabilities/Responsibilities

• Educate and sell health care professionals on marketed products.
• Build strategic relationships with KOLs, influences, and accounts.
• Represent Lung LLC at local, regional and national conferences and symposia.
• Responsible for an assigned geographic territory and designated accounts to actively interface with the PAH community.
• Expand the awareness of Lung LLC and our Company’s focus and commitment in the research, development & commercialization of products for pulmonary diseases.

Requirements

• Bachelor Degree in Science, Nursing or equivalent clinical degree is required
• 8-12 years experience within the specialty pharmaceutical or biotech market place successfully selling to specialized physicians, nurses and other healthcare professionals (i.e.; cardiologists, pulmonologists, etc)
• 2-3 years experience selling within the institutional or major teaching centers environments is required
• Expertise in the cardiovascular and/or pulmonary disease therapeutic areas is preferred
• Experience in working with professional community advocacy organizations is helpful
• Position requires 75% travel; Territory spans throughout southern Texas and southeastern Arizona.

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V