J&J Family of Companies Director, Patient Reported Outcomes, (PRO) in Horsham, Pennsylvania
Director, Patient Reported Outcomes, (PRO) - 2206092841W
Janssen Global Services, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Director, Patient Reported Outcomes (PRO) to be located in Raritan, NJ or Horsham, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Global Services, LLC is part of the Janssen Pharmaceutical Companies.
Janssen Global Services, LLC encompasses groups that provide leadership across critical business areas for Janssen including, Global Commercial Strategy Organization; Global Pharmaceuticals Communication and Public Affairs; U.S. Pharmaceuticals Procurement Group; and Pharmaceuticals Group Business Development
The Director, Patient Reported Outcomes (PRO) is part of a strategic Center of Excellence (COE) of Market Access related functions driving Health Economics, Pricing, and Real-World Evidence value.
The Director, Patient Reported Outcomes (PRO) is responsible for the strategic planning and implementation of PRO programs for multiple pharmaceutical compounds in the R&D pipeline. In this role, the PRO Director is the key contact and is responsible for leading all PRO-related activities for assigned compounds and disease areas. In collaboration with the compound development and clinical teams, as well as commercial functions, the PRO Director develops the appropriate strategies for PRO evaluation of pharmaceutical compounds for purposes of product approval, quantifying value, and supporting market access. Core activities include selecting or developing appropriate PRO endpoints and measures for the clinical development program of each compound and recommending and implementing all the research required to support the selection or development of PRO measures, including qualitative research and quantitative evaluation. The PRO Director represents the PRO function on the Compound Market Access Team (CMAT). Important elements of this collaboration include ensuring that the PRO strategy is developed for competitive value, that it aligns with the overall market access strategy and that value driven by PROs is described in the global value dossier – a key deliverable of the CMAT. The PRO Director will be responsible for presenting to senior leaders in Market Access, R&D, and commercial on PRO-related strategies and activities for assigned compounds and disease areas at internal forums and governance meetings.
Additionally, the PRO Director helps to develop the PRO assessment component of the statistical analysis plan in conjunction with the study statisticians prior to database lock. The PRO Director helps to interpret the PRO clinical trial results. The PRO Director helps to prepare relevant sections of documentation and communication for regulatory agencies and HTA agencies to provide the necessary evidence in support of submission activities. S/he is responsible for PRO publication plans and leads the development of abstracts and manuscripts on PRO results from clinical and other studies. The PRO Director also leads or contributes to departmental or company-wide initiatives and represents Janssen in key external meetings/working groups related to PRO.
A minimum of a Master’s degree in the field of Psychology, Psychometrics, Sociology, Health Economics, Biostatistics, Epidemiology, Public Health or Health Services Research is required
A PhD, PharmD or MD is strongly preferred.
A minimum of 6 years of Patient Reported Outcomes experience is required.
A minimum of 4 years of experience in project management is preferred.
Expertise and experience in the strategy, conceptual basis, methodology and application of PRO and other health outcome measures in the context of clinical studies is required.
Expertise and experience with the development, psychometric evaluation and selection of PRO instruments used in clinical studies is required.
Strong working knowledge and application of the 2009 FDA "Guidance for Industry Patient-Reported Outcome Measures: Use in - Medical Product Development to Support Labeling Claims" and other relevant PRO and Patient Focused Drug Development guidances and best practices is required.
Capability of leading teams, influencing teams, and driving decisions is required.
Ability to work effectively as a member of cross-functional teams is required.
Experience with the drug development process in the pharmaceutical industry is strongly preferred. - Regulatory understanding and experience in negotiating PRO label claims is strongly preferred.
Experience with ePRO is preferred.
An understanding of health economics and pricing is preferred.
Experience managing budgets is required.
Excellent oral, written and presentation skills are required.
Ability to work in a matrix environment is required.
The position can be seated in Raritan, NJ or Horsham, PA.
This position will require up to 15% of both domestic and international travel.
The base pay range for this position is MIN $152,500 to MID $229,000
At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
HEOR, RWE, RWV, RWVE
Primary Location NA-US-New Jersey-Raritan
Other Locations NA-US-Pennsylvania-Horsham
Organization Janssen Global Services, LLC (6085)
Travel Yes, 10 % of the Time
Job Function Health Economics R&D
Req ID: 2206092841W
J&J Family of Companies
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