Executive Director, Global Patient Safety Sciences - Rare Disease
Regeneron
August 30, 2026
Remote friendly (Tarrytown, NY)
United States
Medical Affairs
Discover Your Role:
- Contribute senior-level safety expertise to clinical projects across the assigned therapeutic area.
- Serve as a resource for medical review of complex ICSRs and other data sources; provide escalation for ICSR causality assessments.
- Provide oversight for safety signal evaluations and deliver clinical interpretation of emerging safety issues.
- Review benefit-risk assessments (e.g., HHAs) for safety responses to regulatory agency queries and safety documents (e.g., DSURs, PSURs), as appropriate to asset lifecycle stage.
- Develop innovative approaches to core activities integrating new technologies, including AI.
Governance Leadership:
- Influence cross-functional leaders to align priorities and drive enterprise results.
- Approve and provide medical oversight for Risk Management Plans (RMPs).
- Approve responses to medical and clinical health authority queries as needed.
- Oversee cross-functional Safety Monitoring Team (SMT) activities.
- Represent GPS at cross-functional governance meetings (RSOC, IDMC, SPT) and with external parties (e.g., collaborators).
Talent Development & Organizational Leadership:
- Build, coach, and scale a high-performing team; drive succession planning and talent pipelines.
- Lead talent strategy and leadership development initiatives.
This Role Requires:
- Minimum M.D., PA, PhD, or PharmD; board certification or equivalent preferred; MBA advantage.
- 17+ years total PV or relevant pharmaceutical clinical experience.
- 6+ years leading a team with people management experience (matrix experience preferred).
- Preferred: 1–3 years international pharmaceutical activities.
- Proven product safety profile expertise to inform safety assessments and decision-making.
- Experience with global patient safety organization strategy oversight.
- Strong leadership, communication (verbal/written), organizational/workload planning; ability to manage multiple projects.
- Preferred: AI technology experience.
Application Instructions:
- Apply now.
- Contribute senior-level safety expertise to clinical projects across the assigned therapeutic area.
- Serve as a resource for medical review of complex ICSRs and other data sources; provide escalation for ICSR causality assessments.
- Provide oversight for safety signal evaluations and deliver clinical interpretation of emerging safety issues.
- Review benefit-risk assessments (e.g., HHAs) for safety responses to regulatory agency queries and safety documents (e.g., DSURs, PSURs), as appropriate to asset lifecycle stage.
- Develop innovative approaches to core activities integrating new technologies, including AI.
Governance Leadership:
- Influence cross-functional leaders to align priorities and drive enterprise results.
- Approve and provide medical oversight for Risk Management Plans (RMPs).
- Approve responses to medical and clinical health authority queries as needed.
- Oversee cross-functional Safety Monitoring Team (SMT) activities.
- Represent GPS at cross-functional governance meetings (RSOC, IDMC, SPT) and with external parties (e.g., collaborators).
Talent Development & Organizational Leadership:
- Build, coach, and scale a high-performing team; drive succession planning and talent pipelines.
- Lead talent strategy and leadership development initiatives.
This Role Requires:
- Minimum M.D., PA, PhD, or PharmD; board certification or equivalent preferred; MBA advantage.
- 17+ years total PV or relevant pharmaceutical clinical experience.
- 6+ years leading a team with people management experience (matrix experience preferred).
- Preferred: 1–3 years international pharmaceutical activities.
- Proven product safety profile expertise to inform safety assessments and decision-making.
- Experience with global patient safety organization strategy oversight.
- Strong leadership, communication (verbal/written), organizational/workload planning; ability to manage multiple projects.
- Preferred: AI technology experience.
Application Instructions:
- Apply now.