Executive Director, Global Patient Safety Sciences - Rare Disease

Job description

Overview

Build our future together: the Executive Director, Global Patient Safety Sciences, Rare Disease is the first point of contact for all Rare Disease strategy‑related responsibilities across clinical and post‑market drugs in the portfolio. As the product subject matter expert (SME) and Therapeutic Area Head (TAH) for the Rare Disease portfolio, this role defines product safety strategy, establishes the medical safety opinion, and provides the safety scientific POV across both GPS and non‑GPS interactions. The position also acts as a trusted advisor to senior management regarding safety strategies/processes while developing organizational objectives and understanding the impact of decisions across functional areas. The lead is responsible for the development of their team, which is comprised of GPS Leads, and is a member of the GPS Leadership Team (GPS LT).

Work Location: Tarrytown, NY. Hybrid: 4 days per week on‑site; 25% travel may be required.

Responsibilities

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

Act as a resource for medical review for complex ICSR 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 and deliver recommendations for the product safety profile as appropriate for the stage of the asset lifecycle.

Provide safety responses to regulatory agency queries and safety documents (e.g., DSURs, PSURs).

Develop innovative approaches to core activities that integrate new technologies, including AI governance.

Lead 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 the Regeneron Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC), Strategic Program Team (SPT), and with external parties (e.g., collaborators).

Build, coach, and scale a high‑performing team, drive succession planning and talent pipelines, and lead talent strategy and leadership development initiatives that strengthen capabilities across the organization.

Qualifications

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

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

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

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 Qualifications

1–3 years of international pharmaceutical activities.

Experience with AI technologies.

Benefits

Health and wellness programs (e.g., medical, dental, vision, life, and disability insurance).

Fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels.

Compensation

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

EEO Statement

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.

#J-18808-Ljbffr

Who can apply

Review the original listing for work authorization, qualifications and employer requirements.