Senior Director, Global Patient Safety Leader

Regeneron Pharmaceuticals, Inc.; Kentucky; Híbrido; USD 250 000 - 320 000; Tempo integral

Resumo da oferta

Regeneron Pharmaceuticals, Inc. is seeking a Senior Director to join the Global Patient Safety team as the GPS Lead for assigned compounds, focusing on safety surveillance, signal management, and safety communications tailored to asset lifecycle stages.

The role involves leading the Safety Monitoring Team, coordinating with RSOC and IDMC, and driving safety strategies across obesity/metabolism programs. Must excel in a matrix environment and mentor safety professionals.

Qualificações

• 5+ years of total relevant PV or medical field experience with PharmD/PhD/MD.
• 15+ years total relevant PV/medical field experience or equivalent in lieu industry experience in drug safety with DSURs/ PSURs and RMPS; or in clinical development with safety achievements.

Responsabilidades

• Lead GPS activities for assigned compounds, including safety surveillance and signal management.
• Represent GPS on cross-functional teams and chair the Safety Management Team for the compound.
• Develop safety strategies and ensure regulatory compliance with FDA, EU and ICH guidelines.
• Mentor junior safety scientists and collaborate with stakeholders to deliver the safety profile.

Conhecimentos

Pharmacovigilance

Medical field experience

Team leadership

Cross-functional collaboration

Formação académica

PharmD/PhD/MD

Descrição da oferta de emprego

Regeneron Pharmaceuticals, Inc. is seeking a Senior Director to join the Global Patient Safety team as the GPS Lead for assigned compounds, focusing on safety surveillance, signal management, and safety communications tailored to asset lifecycle stages.

The role involves leading the Safety Monitoring Team, coordinating with RSOC and IDMC, and driving safety strategies across obesity/metabolism programs. Must excel in a matrix environment and mentor safety professionals.