VP, Global Patient Safety Sciences, General Medicine

About the role

The VP, Global Patient Safety Sciences (GPS) General Medicine serves as the primary point of contact for General Medicine safety strategy across clinical and postmarketing assets. As the Therapeutic Area Head (TAH) and product subject matter expert (SME), you define safety strategy, establish the medical safety opinion, and provide the scientific point-of-view across GPS and non-GPS interactions. You will advise senior leadership on safety strategies and processes, shape cross-functional decisions, and serve on the GPS Leadership Team (GPS LT). This role also leads and develops a high-performing team.

Responsibilities

• Safety Strategy & Clinical Risk Assessment
• Contribute senior-level safety expertise to clinical programs across the assigned therapeutic area.
• Serve as the medical review resource for complex Individual Case Safety Reports (ICSRs) and other data sources; act as point of escalation for ICSR causality assessments.
• Oversee safety signal evaluations and deliver clinical interpretation of emerging safety issues.
• Review benefit-risk assessments (e.g., HHAs) and provide recommendations appropriate to asset lifecycle stage, including responses to health authority queries and safety documents (e.g., DSURs, PSURs).
• Develop innovative approaches to core safety activities that integrate new technologies, including AI.
• Governance Leadership
• Influence cross-functional leaders to align priorities and drive enterprise outcomes.
• 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 forums, including Regeneron's Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC), Strategic Program Team (SPT), and with external collaborators.
• 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 to strengthen organizational capabilities.

Requirements

• 15+ years of pharmacovigilance (PV) or relevant clinical experience in the pharmaceutical/biotech industry.
• 8+ years of people leadership with demonstrated success leading teams; experience in a matrixed environment is a plus.
• Proven ability to develop a deep understanding of product safety profiles to inform safety assessments, risk evaluations, and decision-making.
• Experience overseeing strategy within a global patient safety organization.
• Strong leadership presence with excellent interpersonal, verbal, and written communication skills.
• Advanced organizational and workload planning skills with the ability to manage multiple projects simultaneously.

Qualifications

• Minimum 5 years of international pharmaceutical activities.
• Advanced degree preferred: M.D., PA, or PharmD; Board Certification or equivalent in a relevant clinical specialty; MBA is an advantage.
• Experience with AI technologies applied to safety science.

Skills

• Pharmacovigilance (PV) or relevant clinical experience.
• Leadership in a matrixed environment.
• Ability to develop a deep understanding of product safety profiles.
• Experience overseeing strategy within a global patient safety organization.
• Strong interpersonal, verbal, and written communication skills.
• Organizational and workload planning skills.
• Experience with AI technologies applied to safety science.

Benefits

Not specified.

Pay

Not specified.

Schedule

Not specified.