Director, Patient Reported Outcomes, (PRO)

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.