Executive Director, Global Patient Safety Sciences - Rare Disease
Regeneron
June 27, 2026
Remote friendly (Tarrytown, NY)
United States
Medical Affairs
Role Overview:
- Serve as product safety SME and Therapeutic Area Head for Rare Disease; define product safety strategy, establish medical safety opinion, and provide safety scientific POV across GPS and non-GPS interactions.
- Advise senior management on safety strategies/processes; develop organizational objectives and assess impact across functional areas.
- Lead GPS Leads and serve on the GPS Leadership Team (GPS LT).
Work Location:
- Tarrytown, NY (Hybrid: 4 days/week on-site); 25% travel may be required.
Responsibilities:
- Provide senior-level safety expertise to clinical projects.
- Support medical review for complex ICSRs and other data sources; escalate ICSR causality assessments.
- Oversee safety signal evaluations and interpret emerging safety issues.
- Review benefit-risk assessments (e.g., HHAs) for regulatory/safety documents (e.g., DSURs, PSURs) as appropriate.
- Develop innovative approaches integrating new technologies (including AI).
Governance Leadership:
- Influence cross-functional leaders; drive enterprise results.
- Approve Risk Management Plans (RMPs) and medical/clinical health authority query responses.
- Oversee Safety Monitoring Team (SMT) activities.
- Represent GPS in governance forums (e.g., RSOC, IDMC, SPT, and with external parties).
Talent Development & Organizational Leadership:
- Build, coach, scale team; drive succession planning and talent pipelines.
- Lead talent strategy and leadership development initiatives.
Requirements:
- MD/PA/PhD/PharmD; Board Certification preferred; MBA advantage.
- 17+ years PV or relevant pharma clinical experience.
- 6+ years leading a team/people management (matrix experience preferred).
- 1–3 years international pharmaceutical activities (preferred).
- Proven product safety profile expertise to inform safety assessments and risk decisions.
- Experience overseeing global patient safety organization strategy.
- Strong leadership, communication, and multi-project planning skills.
- AI technology experience (preferred).
Application:
- Apply now.
- Serve as product safety SME and Therapeutic Area Head for Rare Disease; define product safety strategy, establish medical safety opinion, and provide safety scientific POV across GPS and non-GPS interactions.
- Advise senior management on safety strategies/processes; develop organizational objectives and assess impact across functional areas.
- Lead GPS Leads and serve on the GPS Leadership Team (GPS LT).
Work Location:
- Tarrytown, NY (Hybrid: 4 days/week on-site); 25% travel may be required.
Responsibilities:
- Provide senior-level safety expertise to clinical projects.
- Support medical review for complex ICSRs and other data sources; escalate ICSR causality assessments.
- Oversee safety signal evaluations and interpret emerging safety issues.
- Review benefit-risk assessments (e.g., HHAs) for regulatory/safety documents (e.g., DSURs, PSURs) as appropriate.
- Develop innovative approaches integrating new technologies (including AI).
Governance Leadership:
- Influence cross-functional leaders; drive enterprise results.
- Approve Risk Management Plans (RMPs) and medical/clinical health authority query responses.
- Oversee Safety Monitoring Team (SMT) activities.
- Represent GPS in governance forums (e.g., RSOC, IDMC, SPT, and with external parties).
Talent Development & Organizational Leadership:
- Build, coach, scale team; drive succession planning and talent pipelines.
- Lead talent strategy and leadership development initiatives.
Requirements:
- MD/PA/PhD/PharmD; Board Certification preferred; MBA advantage.
- 17+ years PV or relevant pharma clinical experience.
- 6+ years leading a team/people management (matrix experience preferred).
- 1–3 years international pharmaceutical activities (preferred).
- Proven product safety profile expertise to inform safety assessments and risk decisions.
- Experience overseeing global patient safety organization strategy.
- Strong leadership, communication, and multi-project planning skills.
- AI technology experience (preferred).
Application:
- Apply now.