Executive Director, PV Systems & AI Enablement

BioSpace; Cambridge (MA); In loco; USD 255.000 - 425.000; Tempo pieno

Descrizione del lavoro

Regeneron is seeking an Executive Director to lead Global Patient Safety (GPS) PV systems and enablement, owning the domain requirements, data architecture, PV processes, and AI-enabled capabilities across GPS while maintaining GxP compliance and day-to-day operational reliability.

You will define and execute a forward-thinking PV systems strategy, partner with GD-IT and the AI CoE, translate business needs into system specs, and build a high-performing team.

Competenze

• Minimum Bachelor's Degree with 17+ years in pharmacovigilance or PV systems.
• Deep understanding of PV processes, safety databases, and reporting tools.
• Strong knowledge of AI and analytics in regulated PV environments.
• Ability to design PV systems and AI-enabled solutions compliant with global regulations.
• Experience leading cross-functional Safety, IT and data/AI teams.
• Familiarity with AI governance, validation, and compliance for PV systems.

Mansioni

• Serve as domain PV expert on safety data, processes, and regulations across GPS.
• Define and own GPS PV systems forward-looking strategy and AI-enabled capabilities.
• Define and communicate the functions vision aligned with enterprise goals.
• Collaborate with GPS leads to align priorities and develop an integrated roadmap.
• Engage with GD-IT and technology teams to execute the GPS roadmap.
• Own and maintain GPS PV systems roadmap balancing modernization and compliance.
• Identify opportunities to leverage AI and analytics within PV processes.
• Oversee AI governance, validation, and implementation.
• Ensure PV systems comply with GxP and data integrity.
• Translate requirements into PV systems specs with stakeholders.
• Provide strategic oversight of PV systems like databases and analytics platforms.
• Liaise with enterprise technology partners representing PV systems.
• Oversee vendor performance and PV systems modernization delivery.
• Build and scale a high-performing team; talent strategy.

Conoscenze

PV systems

AI in PV

Data architecture

Cross-functional leadership

Regulatory compliance

Vendor management

Formazione

Bachelor's degree

MS preferred

Descrizione del lavoro

Regeneron is seeking an Executive Director to lead Global Patient Safety (GPS) PV systems and enablement, owning the domain requirements, data architecture, PV processes, and AI-enabled capabilities across GPS while maintaining GxP compliance and day-to-day operational reliability.

You will define and execute a forward-thinking PV systems strategy, partner with GD-IT and the AI CoE, translate business needs into system specs, and build a high-performing team.