Senior Director, Global Patient Safety - Obesity

Role Summary

Senior Director, Global Patient Safety - Obesity. Responsible for leading GPS activities for obesity/metabolism compounds, overseeing safety surveillance, signal management, and safety strategy across asset lifecycles. Represents GPS on cross-functional teams and collaborates with stakeholders to deliver the safety profile.

Responsibilities

• Reporting to the Global Patient Safety (GPS) TA Head, serve as the first point of contact for all safety issues for assigned compounds within the TA.
• Direct responsibility for all GPS activities for assigned compounds, including safety surveillance, signal management, communication of the safety profile, benefit-risk assessment, safety responses to regulatory queries, and preparation/review of safety documents (DSURs, PSURs, development RMPs, RMPs, etc.) and related clinical documents (Investigator Brochures, protocols, clinical study reports, etc.).
• GPS Lead is the GPS representative on the cross-functional Strategic Program Team (SPT) and Chair of the Safety Management Team (SMT) for the compound.
• Lead safety strategy and ensure optimal GPS support, collaborating with stakeholders to deliver the safety profile and strategy.
• Assigned compounds include obesity/metabolism products at various development stages.
• Ability to work with and influence colleagues in a matrix environment within and outside GPS, 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 industry experience in drug safety, including significant experience with PSURs/DSURs/(d) RMPS; or in clinical development with safety achievements (e.g., ISS support or CSR content).
• Demonstrated experience in specialty TAs incorporating advanced therapies (e.g., gene therapy) into pharmacovigilance practices
• Ability to apply and critically analyze FDA, EU, and ICH guidelines/regulations governing pharmacovigilance in clinical and post-marketing environments
• Subject matter expert internal and external to GPS for assigned compounds with relevant clinical industry experience in the therapeutic area
• Thorough understanding of drug development and its context for safety surveillance
• Proven ability to lead and develop a diverse team of safety professionals
• Ability to work across organizational levels, clearly communicating safety viewpoints and recommended risk management activities
• Ability to utilize GPS safety database for medical case review and simple queries

Skills

• Cross-functional leadership
• Safety strategy development
• Medical review for complex ICSRs and data sources
• Regulatory knowledge for pharmacovigilance
• SOPs and process improvement