Executive Director, Global Patient Safety Sciences - Rare Disease

Job description

Overview

The Executive Director, Global Patient Safety Sciences, Rare Disease serves as the primary contact for all Rare Disease strategy across clinical and post‑marked products. As product subject matter expert and Therapeutic Area Head, the role defines product safety strategy, establishes medical safety opinion, and provides safety scientific POV across GPS and non‑GPS interactions. The director advises senior management on safety strategies, develops organizational objectives, and owns development of a team of GPS Leads as a member of the GPS Leadership Team.

When & Where

Work Location: Tarrytown, NY

Hybrid: 4 days per week on‑site

25% travel may be required.

Discover Your Role

Contribute senior‑level safety expertise to clinical projects across the assigned therapeutic area.

Act as a resource for medical review for complex ICSR reports and other data sources of assigned compounds and serve as point of 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) written by Safety Sciences Delivery and recommend the product safety profile as appropriate for the stage of the asset lifecycle during safety responses to regulatory agency queries and safety documents (e.g., DSURs, PSURs).

Develop innovative approaches to delivering core activities that integrate 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 & clinical health authority queries as needed.

Oversee cross‑functional Safety Monitoring Team (SMT) activities.

Represent GPS at cross‑functional governance meetings including Regeneron’s Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC), Strategic Program Team (SPT), and with other parties external to Regeneron (e.g., collaborators).

Talent Development & Organizational Leadership

Build, coach, and scale a high‑performing team, and drive succession planning and talent pipelines.

Lead talent strategy and leadership development initiatives that strengthen capabilities across the organization.

This Role Requires

Minimum M.D., PA, PhD or PharmD Degree; Board Certification or equivalent in relevant clinical specialty preferred; MBA is an advantage.

17+ years total experience in PV or relevant clinical experience in the pharmaceutical industry required.

6+ years of leading a team and people management experience, added benefit if in a matrixed environment.

Preferred 1‑3 years of international pharmaceutical activities.

Proven track record in developing a deep understanding of the products’ safety profile, supported by in‑depth product knowledge to inform safety assessments, risk evaluations, and decision‑making.

Experience with oversight of strategy within a global patient safety organization.

Strong leadership capabilities and presence, interpersonal, verbal and written communication skills, organizational and workload planning skills, and ability to manage multiple different projects simultaneously.

Preferred experience with AI technologies.

Regeneron is an equal‑opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company’s business.

Salary Range (annually): $285,600.00 – $475,900.00

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Who can apply

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