Associate Director, Patient Reported Outcomes

Johnson & Johnson•Raritan, NJ

1d•Hybrid

About The Position

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 jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. 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 Associate Director, Patient Reported Outcomes, to be located in Raritan, NJ. Purpose: 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 cross-functional teams 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.

Requirements

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.
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.

Nice To Haves

Experience managing budgets is preferred 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.

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 and cross-functional team members 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
Preparing internal communications and presentations e.g. PRO strategy documents
PRO analyses and sections of dossiers for HTA submissions
Abstracts and manuscripts presenting PRO results.
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.

Benefits

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 Colorado –48 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
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits