Director Epidemiology is a member of the Global Epidemiology organization within Pharmacovigilance and Patient Safety (PPS). Major responsibilities include leading the epidemiology strategy and delivery for specific products in collaboration with other PPS and cross-functional team members. The epidemiology strategy encompasses (a) Pharmacoepidemiology studies to evaluate the safety, including PMR’s and PASSs and other regulatory requirements; (b) epidemiologic analysis to support thorough signal evaluation and interpretation; (c) collaborative development of RMPs and Benefit-risk assessments (d) identification and determination of appropriate epidemiologic data sources to support decision making in the context of safety signals, (d) As a member of a cross-functional asset team, including Pharmaceutical Development, Medical Affairs, HEOR, and Statistics, contribute to product strategy and lead real-world data and evidence solutions to further understanding of the benefit-risk and evolving safety profile of drugs. This person is also responsible (indirectly or through direct oversight) for developing and leading more junior epidemiologists and overseeing statisticians/programmers. He or she must have an excellent understanding of data sources (e.g. claims and electronic medical record data sets) and epidemiologic analysis using such databases. This person maintains a high-level understanding of the US and international safety regulations and current regulatory safety review processes.
Core Job Responsibilities:
- Define epidemiologic strategy, vision, for an area or asset, and ensure delivery of high-quality pharmacoepidemiologic studies and evidence.
- Contribute as a subject matter expert through participation in cross-functional teams, committees (as assigned), and in response to internal stakeholder requests.
- Propose, design and oversee the execution of epidemiologic analyses to support knowledge gaps as needed (i.e.: background disease epidemiology, support signal evaluations, etc.)
- Ensure the delivery of relevant content for benefit-risk assessments, Risk Management Plans, and other safety and regulatory documents.
- Support product launches by strategic contribution to the assessment of the need for use of observational data, evaluation of data sources, design and conduct of observational studies
- Ph.D. Epidemiology or equivalent or MD/MPH or MD/MSc in epidemiology
- Minimum of 5 years of applied epidemiology or outcomes research experience
- At least three years of experience in the pharmaceutical industry.
- Preference given to individuals with 1-2 years of line management experience. (optional)
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: Yes, 10 % of the Time
Job Type: Experienced