Senior Director, Global Patient Safety - Obesity

Role Summary

Senior Director, Global Patient Safety - Obesity at Regeneron. Leads safety strategy and GPS activities for obesity/metabolism compounds, serving as the primary safety contact and cross-functional representative for assigned assets.

Responsibilities

• Reporting to the Global Patient Safety Therapeutic Area Head, serve as the first point of contact for all safety-related issues for the assigned compounds within the TA.
• Oversee all GPS activities for assigned compounds, including safety surveillance, signal management, safety communications, benefit-risk assessment, responses to regulatory queries, and review of safety documents and clinical documents.
• Act as GPS representative on the cross-functional Strategic Program Team and chair the Safety Management Team for the compound.
• Lead safety strategy, ensuring optimal GPS support and collaboration with stakeholders to deliver the safety profile and strategy.
• Manage safety activities across various stages of development for obesity/metabolism products.
• Collaborate in a matrix environment with GPS and external partners, including senior management.

Qualifications

• 5+ years of total relevant experience in PV and/or relevant medical field with PharmD / PhD / MD degree
• 15+ years of total relevant experience in PV and/or relevant medical field or equivalent in lieu industry experience in drug safety, including experience with PSURs/DSURs/d RMPS, or in clinical development with demonstrated safety achievements
• Demonstrated experience in specialty TAs incorporating advanced therapies such as gene therapy into pharmacovigilance practices
• Ability to apply and analyze FDA, EU and ICH guidelines governing pharmacovigilance in clinical and post-marketing environments
• Subject matter expert for assigned compounds with relevant clinical industry experience in the therapeutic area
• Thorough understanding of drug development and safety surveillance context
• Proven ability to lead and develop a diverse safety team in a constructive, goal-oriented environment
• Ability to communicate safety viewpoints and findings across organizational levels and recommend risk management actions
• Ability to use GPS safety database for medical case review and queries

Skills

• Cross-functional collaboration
• Safety strategy development
• Regulatory science and compliance
• Medical review of complex data
• SOPs and process improvement
• Mentoring and leadership in safety science

Education

• PharmD, PhD, or MD required

Additional Requirements

• Experience working in matrix organizations and with external partners (e.g., alliance partners, CROs)