Senior Director, Global Patient Safety Leader

Regeneron Pharmaceuticals, Inc; Cambridge (MA); On-site; USD 242,000 - 403,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits (medical, dental, 


life and disability

Paid time off

Family support benefits

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Senior Director GPS Lead to join the Global Patient Safety team in a role focused on safety strategy, signal management, and regulatory responses for obesity/metabolism compounds.

The position requires leading cross‑functional Safety Monitoring Team activities, collaborating with RSOC, IDMC, and SPT, and mentoring safety scientists. On‑site work 4 days/week with up to 25% travel.

Qualifications

• 5+ years in PV and/or relevant medical field; PharmD/PhD/MD degree.
• 15+ years in PV or equivalent with drug safety experience; including DSUR/PSUR/ CSR.
• Experience with safety strategies for advanced therapies; ability to influence in matrix environments.
• Ability to interpret FDA, EU, ICH guidelines for safety surveillance in trials and post‑marketing.

Responsibilities

• Lead GPS activities for assigned compounds, including safety surveillance and signal management.
• Develop safety strategy and ensure optimal support from GPS for safety profile delivery.
• Chair Safety Management Team and represent GPS on cross‑functional teams.
• Review regulatory inquiries and safety documents (DSURs, PSURs, RMPs) and clinical reports.
• Mentor junior safety scientists and cultivate cross‑functional relationships.

Skills

Pharmacovigilance

Leadership

Cross-functional collaboration

Regulatory knowledge

Safety surveillance

Education

PharmD / PhD / MD

Job description

Regeneron Pharmaceuticals, Inc. is seeking a Senior Director GPS Lead to join the Global Patient Safety team in a role focused on safety strategy, signal management, and regulatory responses for obesity/metabolism compounds.

The position requires leading cross‑functional Safety Monitoring Team activities, collaborating with RSOC, IDMC, and SPT, and mentoring safety scientists. On‑site work 4 days/week with up to 25% travel.