Director Global Patient Safety Sciences (Cardiovascular and Metabolism)
- Regeneron Pharmaceuticals, Inc.
- Basking Ridge, New Jersey
- Start date
- Mar 23, 2023
- Administration, Clinical, Manufacturing & Production
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Pharm Country, Best Places to Work
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) assigned within the Cardiovascular and Metabolism (CVM) therapeutic area 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 efficient support from within GPS and works collaboratively with other departments 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.
In this role, a typical day might include the following:
- This Director position is directly responsible for all aspects of Global Patient Safety activities for assigned compounds and products in the Cardiovascular and Metabolism (CVM) therapeutic area 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 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
- 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 track record to lead and develop a diverse team of Safety Professionals in a constructive, goal-oriented environment.
- An ability to work across organizational levels, optimally 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.
Salary Range (annually)$182,800.00 - $304,600.00
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
Stock Symbol: REGN
Stock Exchange: NASDAQ
- Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
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