Director, Epidemiology

Job Description: Under the direction of the Immunology Dermatology Lead in Global Epidemiology, the Director leads or supports one or more assets in the Abb Vie 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 Abb Vie'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 Abb Vie 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.

Required Qualifications: MD-PhD or PhD in epidemiology, pharmacoepidemiology, or a closely related discipline, with 3 or more years of industry experience; orMPH/MS in epidemiology, pharmacoepidemiology, or a closely related discipline, with 10 or more years of industry experience

Preferred Qualifications: 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. 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. This role can be based anywhere in the United States.

Compensation Range: $ 160500 - 305000 USDWhere We Work Role is primarily site- or office-based but can occasionally be performed remotely. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely*, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.