Senior Director, Global Patient Safety - Rare Disease

Regeneron Pharmaceuticals • Village of Tarrytown, NY

7d • $242,000 - $403,300 • Onsite

About The Position

Regeneron is seeking a Senior Director to join its Global Patient Safety (GPS) team. Based in Tarrytown, NY; Warren, NJ; or Cambridge, MA, the position requires working on site four days per week and may require 25% travel.

Reporting to the Global Patient Safety Therapeutic Area Head, the Senior Director GPS Lead serves as the primary point of contact for safety matters related to assigned compounds within the therapeutic area. The role is directly responsible for GPS activities supporting safety surveillance, signal management, safety-profile communication appropriate to an asset’s lifecycle stage, benefit-risk assessment, responses to regulatory agency queries, safety documents, and review of clinical documents. Assigned compounds include obesity and metabolism products at various development stages.

The GPS Lead represents GPS on cross-functional teams, chairs the compound Safety Management Team, leads safety strategy, and coordinates appropriate support from GPS. The position requires collaboration and influence across GPS and other functions, including with senior management and external stakeholders. The role may also serve as a delegate for the GPS Therapeutic Area Head, General Medicine, and contributes to continuous improvement, mentoring, and development of safety professionals.

Requirements

• At least 5 years of relevant pharmacovigilance (PV) and/or medical-field experience with a PharmD, PhD, or MD degree.
• At least 15 years of relevant PV and/or medical-field experience, or equivalent industry experience in drug safety, including significant experience with PSURs, DSURs, and (development) RMPs; alternatively, clinical development experience with demonstrated safety achievements, such as supporting an ISS or owning CSR content.
• Demonstrated experience in specialty therapeutic areas incorporating advanced therapies, such as gene therapy, into pharmacovigilance practices.
• 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 ability to serve as a subject matter expert for assigned compounds, both within and outside GPS.
• Thorough understanding of drug development and its context as it applies 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 the GPS safety database for medical case review and simple queries.

Responsibilities

• Serve as the first point of contact for safety-related issues for assigned compounds within the therapeutic area.
• Lead GPS activities for assigned compounds and products, including safety surveillance, signal management, safety-profile communication, benefit-risk assessment, regulatory safety responses, safety documentation, and review of clinical documents.
• Lead safety strategy and ensure optimal support from GPS while collaborating with stakeholders to deliver the safety profile and strategy.
• Represent GPS on cross-functional teams, including the Strategic Program Team, Regeneron’s Safety Oversight Committee, Independent Data Monitoring Committees, and teams involving alliance partners or CROs.
• Chair and lead cross-functional Safety Management Team activities for assigned compounds.
• Serve as delegate, as needed, for the GPS Therapeutic Area Head, General Medicine.
• Identify and develop safety strategies and plans for non-compound-specific GPS activities, such as mechanism-of-action 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 organization, cultivate cross-functional relationships, and mentor junior safety scientists.

Benefits

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

What This Job Offers

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