Senior Director Global Patient Safety

Regeneron Pharmaceuticals • Warren, MI

5d • Hybrid

About The Position

Regeneron is seeking a Senior Director to join its Global Patient Safety team and support assigned compounds in a hybrid setting. The role leads compound safety strategy and activities, including surveillance, signal management, safety communication, benefit-risk assessment, and regulatory responses. It also oversees key safety reports and risk-management plans, reviews clinical and safety documents, and serves as a central safety contact across internal and external teams.

The Senior Director represents Global Patient Safety on program, oversight, monitoring, and partner teams; deputizes for the Therapeutic Area Head; and develops broader safety strategies, including mechanism-of-action planning. The role provides complex medical review of individual case safety reports and other compound data, advances procedures and working practices through continuous improvement, and mentors junior safety scientists. The position calls for collaborative influence across matrix teams, including senior management.

Requirements

• Nursing, PharmD, PhD, or MD degree.
• Five or more years of relevant pharmacovigilance and/or medical experience with a listed degree.
• Alternatively, ten or more years of relevant pharmacovigilance/medical experience, or equivalent experience in lieu of a PharmD/PhD/MD, including significant drug-safety reporting and risk-management experience.
• Alternatively, clinical-development experience with demonstrated safety achievements, such as integrated safety summary support or responsibility for clinical study report content.
• Ability to influence colleagues across matrix teams, including senior management.

Nice To Haves

• Clinical and/or industry experience in the relevant therapeutic area.

Responsibilities

• Lead assigned-compound safety activities, including surveillance, signal management, lifecycle-appropriate safety communication, benefit-risk assessment, and regulatory responses.
• Oversee Development Safety Update Reports, Periodic Safety Update Reports, development Risk Management Plans, and Risk Management Plans.
• Review Investigator Brochures, protocols, and clinical study reports.
• Chair the Safety Management/Monitoring Team as the first safety contact, coordinating internal support and representing Global Patient Safety cross-functionally.
• Represent safety on the Strategic Program Team, Regeneron’s Safety Oversight Committee, Independent Data Monitoring Committees, and partner/contract research organisation teams.
• Deputise for the Therapeutic Area Head and develop non-compound safety strategies, including mechanism-of-action planning.
• Provide complex Individual Case Safety Report medical-review expertise and review other compound data sources.
• Develop standard operating procedures, working practices, and guides through continuous improvement and cross-functional relationships.
• Mentor junior safety scientists.
• Influence collaboratively across internal and external matrix teams, including senior management.

Benefits

• Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (medical, dental, vision, life, and disability), paid time off, and family support benefits; availability depends on country and role.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree