[Hiring] Director, Epidemiology @AbbVie

Role 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.

• 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.

Qualifications

• MD-PhD or PhD in epidemiology, pharmacoepidemiology, or a closely related discipline, with 3 or more years of industry experience; or
• MPH/MS in epidemiology, pharmacoepidemiology, or a closely related discipline, with 10 or more years of industry experience.

• Epidemiology experience within Immunology therapeutic area strongly preferred.
• Experienced in independently developing and leading strategic plans for asset-focused epidemiology and real-world observational studies.
• Excellent oral and written communication skills and executive presence in cross-functional settings.
• Experience with regulatory and safety policy and contributing to regulatory and safety documents preferred.

Requirements

• 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.
• This role can be based anywhere in the United States.

Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick).
• Medical/dental/vision insurance.
• 401(k) to eligible employees.
• This job is eligible to participate in our long-term incentive programs.