Regeneron · 22 hours ago
Associate Director, Pharmacoepidemiology
United States
Full-time
Remote
Mid, Senior Level, Lead/Staff
$176K/yr - $287K/yr
3+ years expRegeneron is seeking an Associate Director, Pharmacoepidemiology to join our team! The Associate Director will be responsible for managing pharmacoepidemiologic projects and activities in support of marketed and/or development compounds, ensuring compliance with global regulations and internal practices.
BiopharmaBiotechnologyPharmaceutical
Responsibilities
Responsible for implementation of pharmacoepidemiology strategy, generation of real world evidence (RWE), and conduct of regulatory-agency required epidemiologic studies for post-marketing commitments (e.g., PASS, PAES, PMR, DUS, effectiveness of REMS and RMMs) in support of clinical development, regulatory filings, and post-marketing requirements
Actively contribute to other pharmacoepidemiologic activities as a subject matter expert for assigned marketed / development compound(s) or TAs, including but not limited to: (Development) Risk Management Plans; Benefit-Risk analyses; post-approval safety studies that may not be required by a regulatory authority; signal management; responses to regulatory agency queries; regulatory filings, safety surveillance and others
Working closely with Global Patient Safety Leads, Safety Scientists, Regulatory Affairs, Clinical Scientists and other interested parties, provide timely epidemiological and risk management support to project and product teams including design, implementation and analysis of epidemiological studies, review of study proposals from internal and external sources, reviews of the literature, and database activities such as exploring external electronic, patient-level database(s) (administrative claims/EMR/surveys/registries etc) to evaluate safety/benefit questions, disease natural history, and other appropriate epidemiologic data in support of clinical development and regulatory filings
Represent Pharmacoepidemiology on cross-functional teams, including Safety Monitoring Teams, Clinical Development Teams (including with external partners), Regeneron Safety Oversight Committee, and Independent Data Monitoring Committees as needed
Manage and/or conduct non-compound specific pharmacoepidemiology activities (ex. literature review and database queries in support of regulatory fillings)
Actively participate in process improvement activities within the department and Global Patient Safety (GPS) as needed
Qualification
Required
Doctoral degree in epidemiology or a related field, generally with 3+ years of relevant post-doctoral experience. Industry/Regulatory experience preferred
Other post-graduate degree in epidemiology or a related field (e.g. MPH, MSc), generally with 5+ years of relevant experience. Industry/Regulatory experience preferred
Demonstrated achievements of increasing complexity/ responsibility
Function as a subject matter expert on pharmacoepidemiology for assigned compounds/projects with proven history of working on diverse and complex matters
Up-to-date knowledge of US and international regulatory guidances (e.g., pharmacovigilance, RWE, good epidemiology practices) and ability to apply this knowledge to pharmacoepidemiology activities throughout the product life-cycle
Experience utilizing automated healthcare databases (internal and large external databases) to support pharmacoepidemiologic activities Significant experience working with cross-functional teams and external vendors
Excellent written and verbal communication skills
Proven track record of interpersonal, leadership, and project management skills
Benefits
Health and wellness programs (including medical, dental, vision, life, and disability insurance)
Fitness centers
401(k) company match
Family support benefits
Equity awards
Annual bonuses
Paid time off
Paid leaves (e.g., military and parental leave)
Company
Regeneron
Regeneron Pharmaceuticals specializes in the discovery, development, and commercialization of innovative medicines.
10001+ employees
H1B Sponsorship
Regeneron has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (157)
2024 (128)
2023 (128)
2022 (137)
2021 (104)
2020 (122)
Funding
Current Stage
Public CompanyTotal Funding
$15.93MKey Investors
U.S. Department of Health & Human Services
2024-07-11Post Ipo Equity· $2.03M
2023-10-18Post Ipo Equity· $5M
2016-08-22Post Ipo Equity· $8.9M
Leadership Team
Aris Baras
Senior Vice President, Regeneron Pharmaceuticals, General Manager, Regeneron Genetics Center
Bari Kowal
Senior Vice President, Head Development Operations & Portfolio Management
Recent News
Pharmaceutical Technology
2026-01-16
2026-01-16
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