Director, PV Enablement

Role Summary

Director, PV Enablement at Regeneron’s Global Patient Safety Organization. The role focuses on shaping PV governance and enabling PV operations within a global platform, with strategic oversight and partnership across GPS leadership to drive governance, reporting, forecasting, and operational excellence.

Responsibilities

• Lead PV Enablement initiatives and report to the VP of GPS Operations; shape delivery of pharmacovigilance governance to meet operational requirements.
• Provide strategic oversight of global PV governance in partnership with the GPS Leadership Team.
• Develop and maintain operational dashboards and provide status oversight for key GPS projects with the VP of GPS Operations.
• Partner with cross-functional teams to establish operational portfolio forecasting for GPS.
• Offer strategic support for GPS interfaces to enable PV operations and ensure cross-functional alignment.
• Lead operational excellence initiatives, including benchmarking PV innovation and capabilities.
• Identify and assess operational risks across GPS and implement proactive mitigation strategies.
• Demonstrate PV technical expertise and leadership; act as a liaison across Regulatory Affairs, Development Quality, and Regeneron.
• Provide strategic oversight for resource management and operational planning within GPS; drive planning and execution improvements.
• Collaborate on operational optimization with Regulatory Affairs, Global Patient Safety, Development Quality, and Global Development teams; contribute to an environment aligned with the Regeneron Way.
• Translate challenges into tangible outputs and opportunities for team development and GPS culture.

Qualifications

• Minimum Bachelor‚Äôs Degree with 12+ years of relevant PV planning and operations experience; global patient safety operations leadership preferred.
• Subject matter expert in global pharmacovigilance for GPS operations and planning.
• Proven ability to lead and develop a diverse remit with a continuous improvement mindset.
• Strong problem-solving skills with ability to collaborate across complex cross-functional partners.
• Ability to communicate and influence decisions at all levels and deliver high-quality work.
• Track record of leading PV operational and planning initiatives, including governance activities.

Skills

• Strategic PV Operations Oversight and Governance
• Operational Reporting and Forecasting
• Cross-Functional Collaboration
• Regulatory Compliance and Safety Initiatives
• Resource Management and Operational Planning
• Planning and Execution Improvement
• Operational Optimization and Broader Partnerships
• Leadership and Team Development

Education

• Bachelor‚Äôs Degree required; advanced degree or certifications in PV/Regulatory affairs a plus