Johnson & Johnson Careers
Senior Director, Epidemiology and Real-World Evidence, Medical Devices
Requisition ID: 9358180810
The Medical Device (MD) Epidemiology organization in Johnson & Johnson (J&J) group is recruiting for a Senior Director, Safety Epidemiology and Real-World Evidence position to be located in New Brunswick, NJ, with flexibility to work in one of the following J&J offices and visit the New Brunswick office once a month. Other J&J Medical Device company locations are in Titusville NJ, West Chester PA, Raynham, MA, or Cincinnati, OH.
Caring for the world, one person at a time inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. We thrive on a diverse company culture, celebrate the uniqueness of our employees, are committed to inclusion, follow the ethics-based Credo of J&J, and are proud to be an equal opportunity employer.
The Medical Device (MD) Epidemiology organization in Johnson & Johnson (J&J) conducts observational research to support product development, product launch, post-market safety and effectiveness, value assessments, and business development of MD products. The team fosters methodological excellence across Johnson and Johnson’s medical device sector. The team provides skills in using real-world evidence to answer a variety of questions related to safety, product development, label extensions, value demonstration for payers, and other activities.
The Senior Director will lead a team focused on the safety assessment of medical devices and the development of new surveillance methods. The candidate will partner with stakeholders to lead epidemiologic studies to assess the safety of J&J’s devices in the post market environment and develop new methods for proactive safety surveillance of medical devices. The position requires communication and leadership with regulatory agencies, such as the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Chinese FDA, as well as with notifying bodies in the EU. The candidate will be required to write study protocols, use a variety of analytical techniques applied to various databases, and strategize regarding research programs. The Senior Director will be involved with external partners associated with the FDA and EMA, eg, National Evaluation System for health Technology (NEST), Medical Device Innovation Consortium (MDIC), Medical Device Epidemiology Network (MDEpiNet), academic institutions, health systems, and registries to help advance the current thinking and infrastructure of research methods for medical device safety and benefit-risk assessment. The candidate will participate in various activities of the larger Epidemiology Department (Janssen Pharmaceutical and Johnson and Johnson Consumer) and the Office of Chief Medical Officer
The position requires maturity and astute judgement in interpreting observational data to support regulatory decisions regarding device safety.
The position reports to the Vice President of MD Epidemiology, who reports to the Senior Vice President of Epidemiology for J&J in the Office of the Chief Medical Officer.
- A Master’s degree in Epidemiology, Health Services Research, Health Outcomes Research, Biostatistics, or other related field with a minimum of 15 years of Epidemiology or related research work experience in health care is required. A PhD or MD in the same areas with a minimum of 10 years of Epidemiology or related research work experience is preferred.
- In-depth knowledge of healthcare databases, registries, observational study design is required
- Experience with medical devices is preferred
- A sophisticated understanding and ability to analyze and interpret quantitative data required
- Experience writing methods sections of study proposals and protocols is required
- Experience authoring peer reviewed publications using real world data is required
- Experience in cross-functional partnering and working in matrix teams is required
- Experience working with national regulatory authorities, such as the FDA and European Medicines Agency is required
- This position will be located in New Brunswick, NJ, Titusville NJ, West Chester PA, Raynham, MA, or Cincinnati, OH, and may require up to 25% domestic and international travel
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.
United States-New Jersey-New Brunswick
North America-United States-Pennsylvania-West Chester, United States-Massachusetts-Raynham, United States-New Jersey-Titusville, United States-Ohio-Cincinnati, United States-Ohio-Cincinnati
MD&D Global Services LLC (6209)