At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https: //www.jnj.com

Job Function:

Market Access

Job Sub Function:

Health Economics Market Access

Job Category:

People Leader

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America

Job Description:

Director, Patient Reported Outcomes

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https: //www.jnj.com/innovative-medicine

We are searching for the best talent for a Director, Patient Reported Outcomes (PRO) to be located in Raritan, NJ, or Horsham, PA may be considered.

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

Purpose: 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.

You will be responsible for:

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.

Qualifications / Requirements:

• 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 qualitative research and 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 HTAs, health economics and pricing is preferred.
• Experience managing budgets is required.
• Excellent oral, written and presentation skills are required.
• Advanced data interpretation and storytelling skills required
• Ability to work in a matrix environment is required.
• This position will require up to 15% of both domestic and international travel.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https: //www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

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The anticipated base pay range for this position is:

$160, 000 - $276, 000

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https: //www.careers.jnj.com/employee-benefits