The Director provides epidemiology project leadership and strategic input to benefit-risk assessment of biopharmaceutical products; provides guidance in epidemiology study design, including analysis of claims and electronic medical record data sets; and interpretation of observational studies; and maintains an understanding of US and international health authority initiatives and regulations impacting the function of safety science.
- Leads one or more product or product areas while communicating upward and ensuring alignment with management as appropriate.
- Accountable for the delivery of epidemiology content to core safety and regulatory documents including, but not limited to, RMPs, BRPAs, ODAs, Briefing Books and White Papers within their responsible areas.
- Leads the design, management and analysis of observational studies, including registries, providing critical appraisal of observational studies and observational study protocols through active participation in inter-departmental and cross-functional committees (as assigned) and in support of PSTs or other product governance bodies.
- Engages with cross-functional product leadership including pharmaceutical development, Medical Affairs, HEOR and Statistics to achieve team goals.
- Participates in vendor or collaborator selection, protocol development, questionnaire design, statistical analysis plans.
- Provides leadership to address gaps amenable to epidemiologic input as needed (i.e. background disease epidemiology, support signal evaluations, etc.).
- Will be an example of junior staff by demonstrating the AbbVie values and behavioral attributes.
- Participates in PPS leadership discussions and contributes to the strategic direction of PPS.
- MPH or MS with more than 10 years of biopharmaceutical industry experience or PhD degree with 5 or more years of biopharmaceutical industry experience in the field of epidemiology/pharmacoepidemiology, surveillance-related or risk management.
- Demonstrated success in epidemiology project or program leadership.
- Experience with regulatory and safety policy and contributing to regulatory and safety documents.
- Demonstrated ability to lead and publish scientific studies.