Executive Director, Global Patient Safety Sciences - Rare Disease

Work Location

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 Regenerons 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

Qualifications

• 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
• 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

Benefits

Comprehensive benefits vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels!

Equal Opportunity Employer

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.