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.
- 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.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: Yes, 5 % of the Time
Job Type: Experienced