Senior Director Global Patient Safety

Regeneron Pharmaceuticals • Tarrytown, GA

5d • $242,000 - $403,300 • 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 communications, benefit-risk assessment, and regulatory responses. The Senior Director works across internal and external matrix teams and contributes to a science-driven organization focused on developing medicines for serious diseases.

The position also provides leadership and expertise across safety governance, medical review, safety documentation, process improvement, and mentoring. The Senior Director may deputise for the Therapeutic Area Head and develop safety strategies beyond individual compounds. Multiple locations are being considered.

Requirements

• Nursing, PharmD, PhD, or MD degree, with five or more years of relevant pharmacovigilance and/or medical experience.
• 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 supporting an integrated safety summary or having 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

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

What This Job Offers

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