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:
- 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.
This role might be for your if:
- 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
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.