Johnson & Johnson Careers
Director, Epidemiology and Real World Data Sciences - Medical Devices
Requisition ID: 9274190313
Director, Epidemiology and Real-World Data
Sciences - Medical Devices
The Medical Device Epidemiology and Real-World Data Science (Epi-RWDS) organization in Johnson & Johnson (J&J) group is located in the New Brunswick, NJ office.
We are recruiting
for an exciting opportunity as Director, Safety Epidemiology and Real-World
Data Sciences position, which can be located remotely anywhere in the United States. You will visit our team headquarters in the New Brunswick, NJ
office at least once a month.
Caring for the world, one person at a time inspires and unites the people of J&J.
We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the J&J 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 and grow with 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.
Our Epi-RWDS organization in J&J conducts observational research to support product development, product launch, post-market safety and effectiveness, value assessments, and business development of medical devices. The team leads RWD innovation and methodological excellence across J&J’s medical device sector. The team provides skills in using real-world evidence to answer questions related to safety, product development, label extensions, value demonstration for payers, and other activities.
The Director will perform the following for the Medical Device sector:
- You will conduct postmarketing safety studies to meet regulatory requirements, particularly the European Union Medical Device Regulation (EU-MDR) requirements for proactive surveillance,
- You will develop new safety surveillance methods in collaboration with J&J team-mates and in consultation with European Union (EU) regulatory competent authorities and the FDA, and address emerging safety signals and queries from regulatory authorities
- You will partner with other groups at J&J to lead epidemiologic studies using real world data to assess safety and develop new methods for safety surveillance. A priority focus is on RWE surveillance studies to meet EU-MDR requirements using claims, electronic medical record and spontaneously reported complaints data.
- You will communicate with and lead projects with regulatory agencies, such as the US Food and Drug Administration (FDA), Notifying Bodies in the EU and the Chinese FDA.
- You will write study protocols, use a variety of analytical techniques applied to various databases, and strategize regarding research programs.
- You will collaborate with academic institutions, health systems, registries and other research partners on research methods, infrastructure development, scientific advocacy and advance benefit-risk assessment for medical devices.
- You will participate in various activities of medical device businesses (DePuy Synthes, Ethicon, and Cardiovascular and Specialty Solutions), the larger cross-sector Epidemiology Department (Janssen Pharmaceutical and J&J 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. You will report to the Senior Director for Safety, Epi-RWDS, who reports to the Vice President of Epi-RWDS, who reports to the Senior Vice President of Epidemiology for all J&J sectors in the Office of the Chief Medical Officer.
- A PhD or MD in the same areas with at least 10 years of Epidemiology or related research work experience is required. Alternatively, a Master’s degree in Epidemiology, Health Services Research, Health Outcomes Research, Biostatistics, or other related field with at least 12 years of Epidemiology or related research work experience in health care is required.
- In-depth knowledge of healthcare databases, registries, observational study design is required
- Experience with medical devices is preferred
- Experience with adverse event report/complaints signal detection and analysis is preferred
- A sophisticated understanding and ability to analyze and interpret quantitative data is required
- Experience writing methods sections of study proposals and protocols is required
- Experience authoring peer reviewed publications using RWD is required
- Experience in cross-functional collaboration and working in matrix teams in required
- Experience working with regulatory authorities and/or European notified bodies is preferred
- This position may require up to 25% domestic and international travel
J&J Med. Devices & Diag. Grp LA LLC (6081)