The PS/Epidemiology, Science and Execution Senior Manager is an early-to-mid-career scientific role demonstrating an established command of epidemiology and regulatory science. The role requires a solid understanding of core epidemiology concepts, clinical trial safety principles, operational requirements of observational/real-world data studies, and the regulatory frameworks governing patient safety in clinical and post-marketing settings.
Requirements
- Proactively translates and executes the epidemiology strategy and operating model set by Senior/Lead Epidemiology leadership, ensuring high-quality epidemiology activities and inspection-ready outputs.
- Owns end-to-end execution of assigned epidemiology workstreams, from protocol development through study conduct and associated regulatory deliverables, ensuring quality, compliance, and adherence to timelines.
- Directs the planning, preparation, writing, and review of substantial sections of epidemiology protocols and study documents, integrating scientific, operational, and regulatory input to final quality under Senior Epidemiology leadership direction.
- Serves as an expert resource to Safety Management Teams (SMTs) by supporting safety signal evaluation and benefit-risk assessments through targeted literature reviews and secondary analyses aligned to the Senior Epidemiology Leadership scientific approach
- Leads or contributes to continuous improvement initiatives/workstreams to improve quality, compliance, and efficiency, including adoption of new approaches or tools where appropriate
Benefits
- Competitive benefits, services, and programs
- Health insurance
- Retirement plan
- Tuition reimbursement
- Life insurance
- Disability insurance