Senior Director, Global Patient Safety - Rare Disease

Regeneron Pharmaceuticals • Warren, MA

5d • Onsite

About The Position

Regeneron is seeking a Senior Director to join its Global Patient Safety (GPS) team. Reporting to the GPS Therapeutic Area Head, the GPS Lead is the first point of contact for safety issues related to assigned compounds and products within the therapeutic area. The role is directly responsible for GPS activities supporting safety surveillance, signal management, safety-profile communications appropriate to asset lifecycle stage, benefit-risk assessment, responses to regulatory agency queries, safety documents, and reviews of clinical documents. Assigned compounds include obesity and metabolism products at various stages of development.

The GPS Lead represents GPS on cross-functional Strategic Program Teams and chairs the compound’s Safety Management Team. The role leads safety strategy, coordinates support across GPS, and collaborates with stakeholders to deliver the safety profile and strategy. The position is based at one of the listed Regeneron locations and requires on-site work four days per week. Travel may be required, approximately 25%.

Regeneron describes its total rewards package as potentially including annual bonuses or other incentive plans, equity awards, pension or retirement benefits, a 401(k) company match, health and wellness programs, fitness centers, insurance benefits, paid time off, and family support benefits. Availability may depend on country and role.

Requirements

• At least 5 years of total relevant experience in pharmacovigilance and/or a relevant medical field with a PharmD, PhD, or MD degree.
• Alternatively, at least 15 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) RMPs; or clinical development experience with demonstrated safety achievements.
• Demonstrated experience incorporating advanced therapies, such as gene therapy, into pharmacovigilance practices in specialty therapeutic areas.
• Ability to apply and critically analyze relevant FDA, EU, and ICH guidelines, initiatives, and regulations governing pharmacovigilance in clinical-trial and post-marketing settings.
• Relevant clinical industry experience in the therapeutic area of interest and the ability to serve as a subject-matter expert for assigned compounds, internally and externally to GPS.
• Thorough understanding of drug development and its context as applicable to safety surveillance.
• Proven ability to lead and develop a diverse team of safety professionals in a constructive, goal-oriented environment.
• Ability to work across organizational levels, communicate safety viewpoints and findings effectively, and recommend risk-management and minimization activities.
• Ability to use a GPS safety database for medical case review and simple queries.

Responsibilities

• Serve as the first point of contact for safety issues concerning assigned compounds and products within the therapeutic area.
• Lead GPS activities for assigned compounds, including safety surveillance, signal management, safety-profile communication, 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.
• Represent GPS on cross-functional teams, including the Safety Oversight Committee, Independent Data Monitoring Committees, Strategic Program Teams, and teams involving external partners.
• Chair and lead cross-functional Safety Management Team activities for assigned compounds.
• Develop safety strategy and ensure appropriate support from within GPS in collaboration with stakeholders.
• Serve as a delegate for the GPS Therapeutic Area Head, General Medicine, as needed.
• Identify and develop safety strategies and plans for non-compound-specific GPS activities, such as mechanism-of-action activities.
• 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.
• Contribute to continuous improvement within the therapeutic area and GPS, cultivate cross-functional relationships, and mentor junior safety scientists.

Benefits

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

What This Job Offers

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