Full Job Description
The Executive Director, Global Patient Safety Sciences, Rare Disease is the first point of contact for all Rare Disease strategy-related responsibilities across clinical, and post-marketed drugs in the portfolio. As the product subject matter expert (SME) and Therapeutic Area Head (TAH) for the Rare Disease portfolio, this role defines the product safety strategy, establishes the medical safety opinion, and provides the safety scientific POV across both GPS and non-GPS interactions. In addition, the position acts as a trusted advisor to senior management regarding safety strategies/processes while developing organizational objectives and, importantly, understanding the impact of decisions across functional areas. The ED Global Patient Safety Sciences Rare Disease is responsible for the development of their team, which is comprised of GPS Leads. They will serve as a member of the GPS Leadership Team (GPS LT).
When & where:
• Work Location: Tarrytown, NY
• Hybrid: 4 days per week on-site
• 25% travel may be required
Discover your role:
• Contribute senior-level safety expertise to clinical projects across assigned therapeutic area
• Act as a resource for medical review for complex ICSRs, and other data sources of assigned compounds and serves as point of escalation for ICSR causality assessments
• Provide oversight for safety signal evaluations & deliver clinical interpretation of emerging safety issues
• Review benefit-risk assessments (e.g., HHAs) written by Safety Sciences Delivery and recommendations for the product safety profile as appropriate for the stage of the asset lifecycle for safety responses to regulatory agency queries and safety documents (e.g., DSURs, PSURs)
• Develop innovative approaches to delivering on core activities that integrate in new technologies, including AI
Governance Leadership
• Influence cross-functional leaders to align priorities and drive enterprise results
• Approve and provide medical oversight for Risk Management Plans (RMPs)
• Approve responses to medical & clinical health authority queries as needed
• Oversee cross-functional Safety Monitoring Team (SMT) activities
• Represent GPS at cross-functional governance meetings including Regeneron's Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC), Strategic Program Team (SPT), and with other parties external to Regeneron (e.g., collaborators)
Talent Development & Organizational Leadership
• Build, coach, and scale a high-performing team, and drive succession planning and talent pipelines
• Lead talent strategy and leadership development initiatives that strengthen capabilities across the organization.
This role requires:
• Minimum M.D., PA, PhD or PharmD Degree; Board Certification or equivalent in relevant clinical specialty preferred; MBA is an advantage
• 17+ years total experience in PV or relevant clinical experience in the pharmaceutical industry required
• 6+ years of leading a team and people management experience, added benefit if in a matrixed environment
• Preferred 1-3 years of international pharmaceutical activities
• Proven track record in developing a deep understanding of the products' safety profile, supported by in-depth product knowledge to inform safety assessments, risk evaluations, and decision-making
• Experience with oversight of strategy within a global patient safety organization
• Strong leadership capabilities and presence, interpersonal, verbal and written communication skills organizational and workload planning skills along with the ability to manage multiple different projects simultaneously
• Preferred experience with AI technologies
#GDPSJobs
Salary Range (annually)
$285,600.00 - $475,900.00
