Sr Director, Global Patient Safety (Immunology & Inflammation)
- Regeneron Pharmaceuticals, Inc.
- Basking Ridge, New Jersey
- Start date
- Mar 24, 2023
- Administration, Clinical, Science/R&D, Immunology
- Required Education
- Position Type
- Full time
- Pharm Country, Best Places to Work
We are looking for a top-tier safety leader to join or Immunology and Inflammation team and to work closely with the Therapeutic Area (TA) Head.
The Senior Director, serves as the first point of contact (POC) for all safety related issues for the compound(s) assigned within Immunology/Inflammation and will represent our Global Patient Safety (GPS) group on the cross functional Strategic Program Team (SPT) and the Chair of the Safety Management Team (SMT) for the compound. The GPS Lead leads the safety strategy and ensures the optimal support from within GPS and works collaboratively with partners to deliver the safety profile and 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.Functions:
- Directly responsible for all aspects of GPS 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 GPS 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)
- Serves as delegate as needed for GPS Therapeutic Area Head
- Proactively identify and develop safety strategies and planning for non-compound specific GPS activities (mechanism of action etc.)
- Act as a resource for medical review for complex ICSRs, and other data sources of assigned compounds
- Actively applies and provides critical analysis of relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments required.
- Functions as a subject matter expert internal and external to GPS for assigned compounds with relevant clinical industry experience in the therapeutic area of interest.
- Familiarity with development of therapies
- A proven ability to lead and develop a diverse team of Safety Professionals in a constructive, goal-oriented environment.
- 5+ years of total relevant experience in PV and/or relevant medical field with PharmD / PhD / MD degree
- 10+ years of total relevant experience in PV and/or relevant medical field or equivalent in lieu of a PharmD / PhD / MD degree 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)
Salary Range (annually)$216,800.00 - $361,400.00
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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