Director, Global Patient Safety Sciences - General Medicine

About the role

The Global Patient Safety (GPS) Lead role (Director of GPS) serves as the first point of contact (POC) for all safety related issues for the compound(s)/asset(s) assigned within a given therapeutic area (TA), and is the GPS representative on the cross functional strategic program team (SPT) for the compound. The GPS Lead leads the safety strategy and ensures the optimal support from within GPS and works collaboratively with stakeholders to deliver the safety strategy.

Responsibilities

• 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.
• Represents 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.).
• 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.
• 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.
• Lead and develop a diverse team of Safety Professionals in a constructive, goal-oriented environment.
• Work across organizational levels, effectively communicating safety viewpoints and findings as required, and recommended risk management and minimization activities.
• Utilize GPS safety database for purposes of medical case review and simple queries.

Requirements

• Minimum 10+ years of total relevant experience in Pharmacovigilance 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 (ex. supporting an ISS; responsible for CSR content).
• 5+ years of total relevant experience in Pharmacovigilance and/or relevant medical field with PharmD / PhD / MD degree required.
• Clinical experience and/or industry experience in Oncology is a plus.

Qualifications

• Possesses a proven ability to lead and develop a diverse team of Safety Professionals in a constructive, goal-oriented environment.
• 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.
• Ability to utilize GPS safety database for purposes of medical case review and simple queries.