Associate Director, Epidemiology-Immunology

Summary

Join AbbVie as an Associate Director of Epidemiology in Pharmacovigilance & Patient Safety, leading the scientific strategy for pharmacoepidemiology and real-world evidence to support product development and safety. You will design and interpret studies, contribute to regulatory submissions, and provide expertise in regulatory pharmacoepidemiology and real-world study methods. This role involves collaboration with global teams and key partners. The position can be remote within the US. A PhD/PharmD with 3-5 years of experience or an MPH/MS with 5+ years of experience is required. Strong communication, negotiation, and regulatory knowledge are essential.

Requirements

• PhD/PharmD with 3-5 years of experience, or MPH/MS with a minimum of 5 years of experience in epidemiology, outcomes research, or a related discipline
• Demonstrated high level of methodology and technical expertise in regulatory real-world methods, data sources, and study design
• Proven ability to clearly communicate epidemiology concepts, both verbally and in writing, to diverse audiences. Able to articulate study rationale, design, and expected impact on supported programs
• Knowledgeable in current and future policies, practices, trends, and developments affecting the business and organization; understands regulatory pharmaco-epidemiology
• Ability to negotiate skillfully in challenging situations with both internal and external groups, settle differences amicably, gain trust quickly, and effectively balance directness and diplomacy
• Comprehensive understanding of methods for adverse event collection and evaluation, signal detection, and signal validation. Familiar with quality assurance, legal and regulatory functions, database functionalities, and management processes. Knowledgeable of U.S. and international safety regulations and current regulatory safety review processes

Responsibilities

• Lead or contribute to the development of real-world evidence, including study design, protocol and statistical analysis plan development, and execution using various data sources, such as administrative claims and health records data
• Conduct comprehensive literature reviews to support signal assessments, establish background rates for disease states, and develop risk management plans; synthesize and communicate results in both written and presentation formats
• Deliver epidemiology content for core safety and regulatory documents, such as RMPs, BRPAs, ODAs, Briefing Books, and MSAs; lead and participate in vendor or collaborator selection and the creation of study-related materials
• Advance epidemiology research and methodologies, providing expertise on novel and existing techniques to address benefit-risk questions; establish key scientific partnerships to enhance real-world methodologies and capabilities
• Collaborate with global epidemiology teams and key partners, including Pharmaceutical Development, Medical Affairs, HEOR, and Statistics, to achieve team goals
• Development of RWE studies to support asset and disease area strategies, in collaboration with cross-functional partners in Clinical Development, Medical Affairs, HEOR and others

Preferred Qualifications

Industry experience is preferred

Benefits

Remote work option in the US