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, Titusville, NJ, Horsham, PA, Beerse, Belgium or Tokyo, Japan.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
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 HUB of related functions driving Market Access, Pricing, and Real World Evidence value.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
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, 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 a compound, and recommending and implementing all the research required to support the selection or development of PRO measures, including qualitative research. The PRO Director represents the PRO function on the Compound Market Access Team, ensuring that the PRO strategy aligns with the overall market access strategy.
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 prepares 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 is 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.
- Working knowledge of the 2009 FDA "Guidance for Industry Patient-Reported Outcome Measures: Use in - Medical Product Development to Support Labeling Claims" and other relevant 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, Titusville, NJ, Horsham, PA, Beerse, Belgium or Tokyo, Japan.
- This position will require up to 15% of both domestic and international travel.
United States-New Jersey-RaritanOther Locations
North America-United States-New Jersey-Titusville, Asia Pacific-Japan-Tokyo-To-Chiyoda, North America-United States-Pennsylvania-Horsham, Europe/Middle East/Africa-Belgium-Antwerp-BeerseOrganization
Janssen Global Services, LLC (6085)Job Function
Health Economics R&DRequisition ID