Overview As Executive Director, PV Systems & Enablement, you will steer GPS's PV systems strategy and data architecture, shaping modern, compliant ways of working in a GxP environment. You'll partner with GD-IT and the AI CoE to prioritize AI-enabled PV capabilities and oversee the roadmap for safety data platforms, analytics, and tooling. You will lead a high-performing team and ensure alignment with Regeneron's GPS goals, regulatory standards, and operational needs. This is a connecting role that drives innovation while maintaining compliance and reliability at scale.
Compensation / Benefits- annual bonuses or other incentive plans
- equity awards
- pension or retirement benefits
- 401(k) company match
- health and wellness programs
- paid time off
Responsibilities- Define and own the PV systems forward-looking strategy, including data architecture and AI-enabled capabilities
- Collaborate with GPS leaders and GD-IT to develop and execute an integrated PV roadmap
- Oversee PV systems modernization while preserving regulatory compliance and day-to-day operations
- Identify opportunities to apply AI and advanced analytics within PV processes and guide solution design, validation and implementation
- Prioritize AI use cases in partnership with enterprise AI CoE and manage governance
- Drive user adoption and ensure ongoing compliance for AI deployments across GPS
- Translate business requirements into clear PV system specifications with stakeholders
- Provide strategic oversight of PV systems (safety databases, signal detection tools, analytics platforms)
- Serve as liaison with enterprise technology partners (GD IT, Cloud, Dev Ops, AI CoE, Compliance)
- Oversee vendor performance, contracts, and modernization project delivery
- Build, coach, and scale a high-performing team; lead talent strategy and leadership development
- Influence cross-functional leaders to align PV priorities and enterprise results
Key requirements- 15+ years of experience in pharmacovigilance, safety systems, PV systems modernization, data science, or AI-enabled capabilities in life sciences
- Deep understanding of PV processes and systems (safety databases, signal detection, reporting platforms)
- Strong knowledge of AI and advanced analytics in regulated environments
- Ability to assess and design PV systems and AI solutions meeting global regulatory and quality expectations
- Experience modernizing PV systems and safety operations including AI-enabled capabilities
- Experience leading cross-functional initiatives with Safety, IT, and data/AI teams
- Familiarity with AI governance, validation, and compliance for PV systems in regulated settings
- leadership and people management
- cross-functional collaboration
- strategic thinking
- PV systems modernization
- AI-enabled PV capabilities (e.g., agentic AI, Claude, Copilot)
- data architecture for PV
