Posted in: Executive Management in Chicago | Posted: |
Job Description
Under the direction of the Oncology Therapeutic Area (TA) Head in Global Epidemiology, the Director serves as the Epidemiology Asset Strategy Lead for one or more assets in the AbbVie oncology portfolio; provides epidemiology project leadership and strategic input to the benefit-risk assessment of biopharmaceutical products; provides guidance in epidemiology study design, including analysis of real-world data sources; 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.
· As the Global Epidemiology Asset Strategy Lead, develop and execute the function’s RWE strategy plan to evidence that proactively support assets in AbbVie’s oncology portfolio throughout the product lifecycle.
· Maintain clear communication channels with key stakeholders and partners (Development, Safety, Regulatory Affairs, HEOR, Medical Affairs, Precision/Molecular Medicine, and Genetics Research Center) to ensure team resources are focused on critical asset support and related initiatives.
· Lead or manage more junior staff within the Department 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.
· Author or serve as internal departmental reviewer for relevant epidemiology sections of regulatory submissions – ODDs, CSRs, RMPs, DSURs, PSURs, PSPs, and PIPs.
· In collaboration with the Oncology TA Head, evaluate potential data sources and their applicability (fit for purpose) for real-world evidence generation to address different epidemiologic study questions of interest in support of AbbVie oncology 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.
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
Frequent to continuous computer usage (greater or equal to 50% of the workday) is required