Purpose:

The director provides epidemiology project leadership and strategic input to inform the benefit-risk assessment of biopharmaceutical products; provides guidance in pharmaco-epidemiology study design and execution, including analysis of claims and electronic medical record data; develops internal best practices aligned with current regulatory standards to ensure use of sound, fit-for-purpose methodology to inform decisions across the enterprise’s pipeline; and maintains an understanding of US and international safety health authority initiatives and regulations impacting the function of safety science.

Responsibilities:

• Works in a dynamic and fast-paced environment to plan, develop and execute pharmaco-epidemiology/real-world evidence across a broad and expanding portfolio.
• Provides leadership for a team of professionals who deal with various aspects of epidemiology and data related to epidemiology.
• Contributes to the strategy, vision, and processes of the department and PPS.
• Provides expert epidemiological input into establishing internal standards, processes and policies for the use of observational/epidemiological data and the conduct of observational studies.
• Provides expertise on pharmaco-epidemiology and real-world evidence strategies s to a variety of stakeholders across Abbvie.
• Identifies data sources and relevant to safety science in consideration of their scientific value, financial impact,
• Identifies opportunities for collaboration and partnerships, represents the enterprise in scientific and regulatory policy discussions, maintains presence as a well-respected expert in pharmaco-epidemiology in the external scientific community.
• Provides input on patient registry design and interpretation of data.
• Ensures use of sound, robust, fit-for-purpose methodology in the generation of pharmaco-epidemiology/real-world evidence across the enterprise’s pipeline.
• Maintains current knowledge of epidemiologic methods, data resources as well as their applications in benefit-risk evaluation, and current health authority initiatives and regulations impacting the function of safety science.

• PhD in epidemiology or MD/MPH or MD/PhD in epidemiology

• Minimum of 5 years of experience in the conduct of epidemiological studies and/or using population-based databases

• At least 3 years in a drug safety environment

• Preference given to individuals with formal clinical training, proficiency in statistical analysis computing, experience building effective teams, and knowledge of the financial impact of projects.