- 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 sophisticated 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 encouraging cross functional relationships and mentoring junior safety scientists.
- 10+ years of total relevant experience in PV and/or relevant medical field or equivalent in lieu of a
- Doctorate degree required. MD degree preferred. PharmD / PhD will be considered with deep safety lead 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).
- Oncology experience is required.
- 5+ years of total relevant experience in PV and/or relevant medical field with PharmD / PhD / degree
- Clinical experience and/or industry experience in the TA of interest is a plus
Director, Global Patient Safety - Dublin, Ireland - Regeneron Pharmaceuticals, Inc
Description
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 the Solid Oncology therapeutic area (TA), and is the GPS representative on the cross functional strategic program team for the compound. The GPS Lead owns the safety strategy and ensures the optimal support from within GPS and works collaboratively with collaborators 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.
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.)
A typical day in this role might include the following:
This role might be for your if:
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