Director, Global Patient Safety Sciences - Oncology

Regeneron Pharmaceuticals • Warren, MA

4d • Hybrid

About The Position

Regeneron is seeking a Director to lead Global Patient Safety (GPS) activities for assigned compounds and products in Oncology. The GPS Lead is the primary point of contact for safety matters for assigned assets and represents GPS on cross-functional strategic program teams. The role leads the safety strategy, coordinates support across GPS, and works with internal and external stakeholders—including senior management—in a matrix environment. It has an impact on drug development, operations, and commercialization across relevant global territories.

The Director is responsible for safety surveillance, signal management, communicating the safety profile in light of each asset’s lifecycle, benefit-risk assessment, regulatory safety responses, and safety documentation. The role also reviews clinical documents, leads cross-functional Safety Monitoring Team activities, provides medical review support for complex individual case safety reports and other data, and contributes to GPS procedures and continuous improvement. The Director serves as a subject matter expert for assigned compounds and helps develop safety professionals.

The position is hybrid, based in Tarrytown, New York; Warren, New Jersey; or Cambridge, Massachusetts, with four days per week on site. Regeneron offers a competitive total rewards package that may include incentive plans, equity awards, retirement benefits, health and wellness programs, insurance, paid time off, and family support benefits, depending on country and role.

Requirements

• At least 10 years of total 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 or post-marketing RMPs; alternatively, clinical-development experience with demonstrated safety achievements, such as supporting an ISS or owning CSR content.
• For candidates with a PharmD, PhD, or MD, at least 5 years of total relevant experience in pharmacovigilance and/or a relevant medical field.
• Ability to apply and critically analyze applicable FDA, EU, and ICH pharmacovigilance guidance and regulations.
• Ability to work across organizational levels and communicate safety findings and viewpoints effectively.
• Ability to use the GPS safety database for medical case review and simple queries.
• Proven ability to lead and develop a diverse team of Safety Professionals.

Nice To Haves

• Clinical experience and/or industry experience in Oncology.

Responsibilities

• Serve as the first point of contact for safety-related issues for assigned compounds and products, and represent GPS on cross-functional strategic program teams.
• Lead the safety strategy for assigned assets and coordinate appropriate support from within GPS and with stakeholders.
• Oversee safety surveillance, signal management, safety-profile communication, and benefit-risk assessments throughout the asset lifecycle.
• Prepare or oversee safety responses to regulatory agency queries and 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 GPS on cross-functional and external teams, including the Regeneron Safety Oversight Committee, Independent Data Monitoring Committees, Strategic Program Teams, alliance partners, and CROs.
• Proactively identify and develop safety strategies and plans for non-compound-specific GPS activities, such as mechanism-of-action safety topics.
• Provide medical-review support for complex individual case safety reports 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 GPS, cultivate cross-functional relationships, and mentor junior safety scientists.
• Apply and critically analyze relevant FDA, EU, and ICH pharmacovigilance guidelines, initiatives, and regulations for clinical-trial and post-marketing settings.
• Communicate safety viewpoints and findings across organizational levels and recommend risk-management and minimization activities.
• Use the GPS safety database for medical case review and simple queries.
• Lead and develop a diverse team of Safety Professionals in a constructive, goal-oriented environment.

Benefits

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

What This Job Offers

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