Role Summary
Senior Director, Pharmacoepidemiology will lead cross-functional epidemiology activities to support regulatory filings, clinical development, and post-marketing commitments, acting as an in-house epidemiology subject matter expert and ensuring alignment with global regulations and SOPs.
Responsibilities
- Support the designated pharmacoepidemiology therapeutic area lead and oversee the generation of real-world evidence (RWE) and regulatory agency required epidemiologic studies for post-marketing commitments.
- Contribute to other pharmacoepidemiology activities, including risk management plans, benefit-risk analyses, signal management, responses to regulatory queries, and regulatory filings.
- Collaborate with Global Patient Safety Leads, Safety Scientists, Clinical Scientists, Regulatory Affairs and other functions to design, implement, and analyze epidemiological studies; review study proposals; and conduct database activities using external databases to evaluate safety/benefit questions and related mortality/morbidities.
- Represent Pharmacoepidemiology on cross-functional teams (Safety Monitoring Teams, Clinical Study Teams with external partners, Regeneron Safety Oversight Committee, Independent Data Monitoring Committees).
- Lead non-compound-specific pharmacoepidemiology activities (e.g., literature reviews) in support of regulatory filings.
- Develop and maintain SOPs and Working Instructions; drive process improvement initiatives across GPS and Regeneron as appropriate.
- Manage and/or develop direct reports, contractors, and external vendors as appropriate.
- Build and maintain relationships with external experts to ensure high-quality evidence generation.
Qualifications
- Required: Demonstrated achievements of increasing complexity/responsibility; proven history as a subject matter expert in pharmacoepidemiology with the ability to represent the function internally and externally; up-to-date knowledge of US and international regulatory guidance (pharmacovigilance, RWE, good epidemiology practices) and ability to apply to product life-cycle; experience utilizing automated healthcare databases; significant experience leading cross-functional teams and external vendors; proven leadership experience (people and/or project management); excellent written and verbal communication skills.
- Preferred: Doctoral degree in epidemiology or a related field with 8+ years of relevant post-doctoral experience and 8+ years of Industry/Regulatory experience; other post-graduate degree in epidemiology or related field (e.g., MPH, MSc) with 10+ years of relevant experience and 8+ years of Industry/Regulatory experience.
Education
- Doctoral degree in epidemiology or a related field (preferred with 8+ years of industry/regulatory experience).
- Other post-graduate degree in epidemiology or a related field (e.g., MPH, MSc) with substantial relevant industry/regulatory experience.