Clinical Outcomes Director jobs in Somerset, NJ

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 or Horsham, PA. (2 positions)

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 Associate 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.

KEY RESPONSIBILITIES

• Lead activities under the direction of a PRO Lead:

  • 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.

QUALIFICATIONS  

• A Master’s degree or PhD in the field of psychology, psychometrics, sociology, health economics, biostatistics, epidemiology, public health or health services research, or PharmD.
  

• A minimum of 4 or more years of Patient Reported Outcomes experience is required.
  

• A minimum of 2 or more years of experience in project management is required.
  

• Experience in the strategy, conceptual basis, methodology and application of PRO and other health outcome measures in the context of clinical studies is required.
  

• Experience with the development, psychometric evaluation and selection of PRO instruments used in clinical studies is required.
  

• 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 guidance and best practices is required.
  

• Experience managing budgets is required.
  

• Ability to work effectively as a member of cross-functional teams is required.
  

• Excellent oral, written and presentation skills are required.
  

• Ability to work in a matrix environment is required.
  

• Capable of leading and influencing teams and driving decisions is strongly preferred.
  

• Experience with the drug development process in the pharmaceutical industry is strongly preferred.
  

• Regulatory understanding in negotiating PRO label claims is strongly preferred.
  

• Experience with ePRO is preferred.
  

• This position will require up to 10% of both domestic and international travel.
  

The base pay range for this position is MIN $131,000 to MID $196,000

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.