Additional Information
VP, Global Patient Safety Sciences - General Medicine
The VP, Global Patient Safety Sciences (GPS) - General Medicine serves as the primary point of contact for General Medicine safety strategy across clinical and post‑marketing 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.
In This Role, You Will:
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.
What You Need to Succeed
Required Qualifications
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.
Regeneron · Tarrytown