Director, Global Patient Safety Sciences - Oncology

Regeneron Pharmaceuticals • Village of Tarrytown, NY

5d • $205,000 - $341,600 • Hybrid

About The Position

The Director of Global Patient Safety (GPS) serves as the primary contact for safety-related matters for assigned compounds or assets within a therapeutic area and represents GPS on the compound’s cross-functional Strategic Program Team. The role leads safety strategy, coordinates support from within GPS, and collaborates with stakeholders across the organization and externally, including senior management. It contributes to drug development, operations, and commercialization across relevant global territories.

The Director is responsible for GPS activities for assigned compounds and products, including safety surveillance, signal management, safety-profile communication appropriate to the asset lifecycle, benefit-risk assessment, responses to regulatory agency queries, safety documents, and review of clinical documents. The role also provides medical review expertise, supports continuous improvement and mentoring, and applies relevant pharmacovigilance regulations and guidance in clinical-trial and post-marketing settings.

The position is based in Tarrytown, New York; Warren, New Jersey; or Cambridge, Massachusetts, with a hybrid schedule requiring four days per week onsite.

Requirements

• At least 10 years of relevant experience in pharmacovigilance and/or a relevant medical field, or equivalent industry experience in drug safety, including significant experience with PSURs, DSURs, and (development) RMPs; alternatively, experience in clinical development with demonstrated safety achievements such as supporting an ISS or being responsible for CSR content.
• For candidates with a PharmD, PhD, or MD degree, at least 5 years of relevant experience in pharmacovigilance and/or a relevant medical field.
• Ability to critically analyze and apply relevant FDA, EU, and ICH guidelines, initiatives, and regulations governing pharmacovigilance in clinical-trial and post-marketing environments.
• Ability to lead and develop a diverse team of Safety Professionals.
• Ability to communicate safety findings and viewpoints effectively across organizational levels and recommend risk-management and minimization activities.
• Ability to use a Global Patient Safety safety database for medical case review and simple queries.

Nice To Haves

• Clinical and/or industry experience in oncology.

Responsibilities

• Serve as the first point of contact for safety-related issues concerning assigned compounds or assets within a therapeutic area.
• Lead the safety strategy for assigned compounds and coordinate optimal support from within Global Patient Safety.
• Oversee safety surveillance, signal management, communication of the safety profile, and benefit-risk assessment.
• Prepare safety responses to regulatory agency queries and oversee safety documents, including DSURs, PSURs, development RMPs, and RMPs.
• Review clinical documents, including Investigator Brochures, protocols, and clinical study reports.
• Lead cross-functional Safety Monitoring Team activities.
• Represent Global Patient Safety on cross-functional teams, including the Safety Oversight Committee, Independent Data Monitoring Committees, Strategic Program Teams, and teams involving alliance partners or CROs.
• Develop safety strategies and planning for non-compound-specific Global Patient Safety activities, such as those related to mechanism of action.
• Provide medical-review support for complex ICSRs and other data sources for assigned compounds.
• Participate in developing and maintaining relevant SOPs, working practices, and guides.
• Participate in continuous improvement activities within the therapeutic area and Global Patient Safety, cultivate cross-functional relationships, and mentor junior safety scientists.
• Apply and critically analyze applicable FDA, EU, and ICH pharmacovigilance guidelines, initiatives, and regulations for clinical-trial and post-marketing environments.
• Serve as a subject matter expert for assigned compounds, internally and externally to Global Patient Safety.
• Lead and develop a diverse team of Safety Professionals in a constructive, goal-oriented environment.
• Communicate safety viewpoints and findings across organizational levels and recommend risk-management and risk-minimization activities.
• Use the Global Patient Safety safety database for medical case review and simple queries.

Benefits

• Annual bonuses or other incentive plans may be offered, depending on country and role.
• Equity awards may be offered, depending on country and role.
• Pension or retirement benefits may be offered, depending on country and role.
• 401(k) company match.
• Health and wellness programs.
• Fitness centers.
• Insurance benefits, including medical, dental, vision, life, and disability coverage.
• Paid time off.
• Family support benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: No Education Listed