Director, Global Patient Safety Sciences - Neurology

Role Summary

The Director of Global Patient Safety (GPS) serves as the primary safety contact for assigned assets within a therapeutic area and acts as the GPS representative on the cross-functional strategic program team. The GPS Director leads safety strategy, ensuring support from GPS and collaborating with stakeholders to deliver the safety plan. The role requires the ability to influence colleagues in a matrix environment, including senior management, and contributes to drug development, operations, and commercialization across global territories.

Responsibilities

• This Director position is directly responsible for all aspects of Global Patient Safety activities for assigned compounds and products in support of safety surveillance, signal management, communication of the safety profile as appropriate for the stage in the asset lifecycle, benefit risk assessment, safety responses to regulatory agency queries, safety documents (DSURs, PSURs, development RMPs, RMPs, etc.) and the review of clinical documents (Investigator Brochures, protocols, clinical study reports, etc.)
• Leads cross-functional Safety Monitoring Team (SMT) activities
• Represent Global Patient Safety for assigned compounds on cross-functional teams, including Regeneron’s Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC), Strategic Program Team (SPT) and other teams with members external to Regeneron (alliance partners, CROs)
• Proactively identify and develop safety strategies and planning for non-compound specific Global Patient Safety activities (mechanism of action etc.)
• Act as a resource for medical review for complex ICSRs, and other data sources of assigned compounds
• Actively participate in the development and maintenance of relevant SOPs, working practices and guides
• Actively participates in continuous improvement activities within both the TA and the GPS organization, including cultivating cross functional relationships and mentoring junior safety scientists

Skills

• Ability to apply and provide critical analysis of relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments required.
• Function as a subject matter expert internal and external to GPS for assigned compounds with relevant clinical industry experience in the therapeutic area of interest.
• A proven ability to lead and develop a diverse team of Safety Professionals in a constructive, goal-oriented environment.
• An ability to work across organizational levels, effectively communicating safety viewpoints and findings as required, and recommended risk management and minimization activities.
• Ability to utilize GPS safety database for purposes of medical case review and simple queries.

Qualifications

• Required: Minimum 10+ years of total relevant experience in PV and/or relevant medical field or equivalent of industry experience in drug safety including significant experience with PSURs/DSURs/(d) RMPS; or in clinical development with demonstrated achievements in safety (e.g., supporting an ISS; responsible for CSR content).
• Required: 5+ years of total relevant experience in PV and/or relevant medical field with PharmD / PhD / MD degree required.
• Preferred: Clinical experience and/or industry experience in Oncology is a plus.