Job Description
Under the direction of the Immunology Dermatology Lead in Global Epidemiology, the Director leads or supports one or more assets in the AbbVie immunology portfolio; provides epidemiology project leadership and strategic input to the benefit-risk assessment of biopharmaceutical products; leads epidemiology study design, including analysis of real-world data sources, independently or with additional support; interpretation of real-world evidence; and maintains an understanding of US and international health authority initiatives and regulations impacting the functions of regulatory science and pharmacovigilance, as applicable to RWD/RWE.
Responsibilities:
- Represent Global Epidemiology on cross-functional, matrix sub-teams of overall asset development teams.
- Develop and execute the function’s RWE strategy plan for evidence that proactively supports assets in AbbVie’s immunology portfolio throughout the product lifecycle.
- Collaborate with key stakeholders and cross-functional partners (Clinical Development, Safety, Regulatory Affairs, HEOR, Medical Affairs, Precision/Molecular Medicine) to propose and execute on epidemiology and RWE studies that support key asset strategy needs.
- Lead or manage other staff in the conduct of research planning and non-interventional study execution, including protocol and SAP development, cross-functional alignment, and delivery of final results/study report and peer-reviewed scientific publications.
- Represent the company's position to regulatory authorities in written and verbal communications for regulatory-grade real-world evidence in support of company filings.
- Evaluate potential data sources and their applicability (fit for purpose) for RWE generation to address different epidemiologic study questions of interest in support of AbbVie immunology drug development.
- Maintain current knowledge of principled pharmacoepidemiologic methods, RWD sources and their applications to benefit-risk evaluation, as well as current health authority initiatives and regulations impacting the functions of pharmacovigilance and regulatory science as applicable to RWD/RWE.
- Author and disseminate scientific communications and research articles via presentations at professional conferences and publication in the medical peer-reviewed literature.
- Author or serve as internal departmental reviewer for relevant epidemiology sections of regulatory submissions – ODDs, CSRs, RMPs, DSURs, PSURs, PSPs, and PIPs.