Executive Director, Global Patient Safety Sciences - Rare Disease

Discover Your Role
- Contribute senior-level safety expertise to clinical projects across assigned therapeutic area
- Act as a resource for medical review for complex ICSRs and other data sources; serve as escalation point for ICSR causality assessments
- Provide oversight for safety signal evaluations and deliver clinical interpretation of emerging safety issues
- Review benefit-risk assessments (e.g., HHAs) for safety responses to regulatory queries and safety documents (e.g., DSURs, PSURs)
- Develop innovative approaches to delivering core activities, integrating new technologies including AI

Governance Leadership
- Influence cross-functional leaders to align priorities and drive enterprise results
- Approve and provide medical oversight for Risk Management Plans (RMPs)
- Approve responses to medical and clinical health authority queries as needed
- Oversee cross-functional Safety Monitoring Team (SMT) activities
- Represent GPS at governance meetings (RSOC, IDMC, SPT) and with external parties

Talent Development & Organizational Leadership
- Build, coach, and scale a high-performing team; drive succession planning and talent pipelines
- Lead talent strategy and leadership development initiatives

This Role Requires
- Minimum M.D., PA, PhD, or PharmD; Board Certification (preferred); MBA advantage
- 17+ years PV or relevant pharmaceutical clinical experience
- 6+ years leading a team and people management (benefit: matrix environment)
- Preferred: 1–3 years international pharmaceutical activities
- Proven track record in understanding product safety profile for safety assessments and risk evaluations
- Experience overseeing strategy within a global patient safety organization
- Strong leadership, interpersonal, and communication skills; organizational/workload planning; manage multiple projects
- Preferred: AI technology experience

Application instructions: Apply now.