Global Patient Safety Senior Director & SMT Leader

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

Benefits offered by this job

Total rewards package

On-site work 4 days/week

Job summary

Regeneron Pharmaceuticals, Inc. seeks a Senior Director to join Global Patient Safety. This on-site role reports to the GPS TA Head and acts as the safety lead for assigned compounds, with work locations in Tarrytown, NY; Warren, NJ; or Cambridge, MA.

Four days on site and up to 25% travel are expected. Lead the cross-functional Safety Monitoring Team, represent GPS on RSOC/IDMC/SPT, mentor junior scientists, and develop safety strategies and SOPs.

Qualifications

• 5+ years of total relevant experience in PV and/or medical field with PharmD / PhD / MD degree.
• 15+ years of total relevant experience in PV and/or medical field or equivalent in lieu industry experience in drug safety including significant experience with PSURs/DSURs/(d) RMPS; or in clinical development with safety achievements.
• Demonstrated experience in specialty TAs incorporating advanced therapies, such as gene therapy into pharmacovigilance practices.
• Ability to apply and provide critical analysis of FDA, EU and ICH guidelines governing pharmacovigilance activities.
• Subject matter expert internal and external to GPS for assigned compounds with clinical industry safety experience.

Responsibilities

• Leads cross-functional Safety Monitoring Team activities and represents GPS on cross-functional teams (RSOC, IDMC, SPT, alliances).
• Acts as delegate for GPS Therapeutic Area Head when needed.
• Develops safety strategies and planning for GPS activities, including mechanism of action considerations.
• Supports medical review for ISSCs and data sources of assigned compounds.
• Maintains SOPs, practices, and guides; mentors junior safety scientists.

Skills

Safety leadership

Cross-functional collaboration

Regulatory knowledge (FDA/EU/ICH)

Team leadership

Medical/science background

Education

PharmD / PhD / MD

Job description

Regeneron Pharmaceuticals, Inc. seeks a Senior Director to join Global Patient Safety. This on-site role reports to the GPS TA Head and acts as the safety lead for assigned compounds, with work locations in Tarrytown, NY; Warren, NJ; or Cambridge, MA.

Four days on site and up to 25% travel are expected. Lead the cross-functional Safety Monitoring Team, represent GPS on RSOC/IDMC/SPT, mentor junior scientists, and develop safety strategies and SOPs.