Director Global Patient Safety
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 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. This position requires the ability to work with and influence colleagues in a matrix environment within and external to GPS including senior management. The GPS Director joins Regeneron’s industry leading scientific organization, and has a direct impact on drug development, operations, and commercialization in all relevant global territories.
Essential Functions required for the job. List both technical and managerial requirements if applicable.
- 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
- Multiple Director openings available across therapeutic areas: Cardiovascular & Metabolism (CVM), Infectious Disease (ID), Pain & Neurology, Oncology, and Ophthalmology.
· 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.