Johnson & Johnson Careers
Associate Director, Patient Reported Outcomes
Requisition ID: 6296191001
Janssen Global Services, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, Patient Reported Outcomes (PRO) to be located in Raritan, NJ, Titusville, NJ, or Horsham, PA.
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.
Director, Patient Reported Outcomes (PRO) works closely with the PRO team to
facilitate PRO-related activities in support of studies conducted for products
in development in the Janssen R&D organization. The PRO Associate Director
is responsible for managing PRO-related activities for assigned compounds in
development, as well as for providing scientific expertise in measurement and
psychometric analytic issues across therapeutic areas. The PRO Associate
Director may be responsible for leading the PRO program and be responsible for
all PRO-related aspects for a compound. The PRO Associate Director provides
background information on competitor drug PRO research, conducts PRO literature
searches, conducts qualitative research, works with the clinical team to
incorporate PRO instruments into clinical studies, oversees analyses and
publications, and generally represents the PRO function in clinical trial
working groups and other teams.
- Partner with the PRO Lead to:
- Provide clinical teams with the information necessary for the appropriate incorporation of PRO measures in clinical studies
- Provide information and guidance in choosing appropriate PRO instruments for clinical studies
- Determine availability of selected PRO instruments and their translations for inclusion in clinical trials; and to implement any validation studies required; and to provide PRO training and materials for trial investigators
- Ensure appropriate PRO data capture methods (including ePRO) and processes are implemented
- Oversee psychometric analyses and work with statisticians on PROs included in protocols, statistical analysis plans, and clinical study reports
- Participate in preparing relevant:
- Sections of documentation and communication for regulatory agencies in support of submission activities
- PRO analyses and sections of dossiers for HTA submissions
- Abstracts and manuscripts presenting PRO results from clinical studies
- Identify, evaluate and manage projects with researchers and PRO vendors external to the company, including but not limited to qualitative research, cultural validation studies, validation studies for special populations, and quantitative analyses
- Manage budgets and contracts for PRO projects
- Ensure PRO activities are captured in a shared electronic PRO repository.
- A Master’s degree or PhD in the field of psychology, psychometrics, sociology, health economics, biostatistics, epidemiology, public health or health services research, PharmD, or MD is preferred.
- A minimum of 4 years of Patient Reported Outcomes experience.
- A minimum of 2 years of experience in project management.
- Experience in the strategy, conceptual basis, methodology and application of PRO and other health outcome measures in the context of clinical studies.
- Experience with the development, psychometric evaluation and selection of PRO instruments used in clinical studies.
- Working knowledge Patient Focused Drug Development initiatives, 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.
- Ability to work effectively as a member of cross-functional teams.
- Experience managing budgets.
- Excellent oral, written and presentation skills.
- Ability to work in a matrix environment.
- This position will require up to 15% of both domestic and international travel.
- Capable of leading and influencing teams and driving decisions.
- Experience with the drug development process in the pharmaceutical industry.
- Regulatory understanding in negotiating PRO label claims.
- Experience with ePRO.
- An understanding of health economics and pricing.
United States-New Jersey-Raritan-
North America-United States-Pennsylvania-Horsham
Janssen Global Services, LLC (6085)
Health Economics R&D