Senior Director, Global Patient Safety - Obesity

Role Summary

Senior Director, Global Patient Safety - Obesity leads GPS activities for obesity/metabolism compounds, sets safety strategy, and serves as the primary point of contact for safety issues within the therapeutic area. This role requires collaboration across GPS and external partners to deliver the safety profile and risk management plans throughout asset development.

Responsibilities

• First point of contact for all safety-related issues for assigned compounds within the therapeutic area.
• Oversee all GPS activities for assigned compounds, including safety surveillance, signal management, safety communications, benefit-risk assessment, and responses to regulatory inquiries.
• Review safety documents (DSURs, PSURs, development RMPs, RMPs) and clinical documents (Investigator Brochures, protocols, clinical study reports, etc.).
• Represent GPS on cross-functional Strategic Program Team (SPT) and chair the Safety Management Team (SMT) for the compound.
• Lead safety strategy and ensure optimal support from GPS, collaborating with stakeholders to deliver the safety profile and strategy.
• Manage compounds across various stages of development in obesity/metabolism.
• Engage with colleagues in a matrix environment, including senior management.

Qualifications

• 5+ years of total relevant experience in pharmacovigilance and/or relevant medical field with PharmD, PhD, or MD degree.
• 15+ years of total relevant experience in pharmacovigilance and/or relevant medical field or equivalent industry experience in drug safety, including significant experience with PSURs/DSURs and RMPS; or in clinical development with demonstrated safety achievements.
• Demonstrated experience in specialty therapeutic areas incorporating advanced therapies, such as gene therapy, into pharmacovigilance practices.
• Ability to apply critical analysis of FDA, EU, and ICH guidelines 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 obesity/metabolism.
• Thorough understanding of drug development and safety surveillance context.
• Proven ability to lead and develop a diverse safety professional team in a constructive, goal-oriented environment.
• Strong cross-organizational communication of safety viewpoints and risk minimization strategies.
• Ability to utilize GPS safety databases for medical case review and queries.

Education

• PharmD, PhD, or MD degree required.