Senior Director, Global Patient Safety - General Medicine

Regeneron's Patient Safety Organization is looking for a Senior Director to join our organization!

• Reporting to the Global Patient Safety (GPS) Therapeutic Area (TA) Head, the Senior Director GPS Lead, serves as the first point of contact (POC) for all safety related issues for the compound(s) assigned within the therapeutic area (TA).

• This position is 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.)

• The GPS Lead is the GPS representative 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 stakeholders to deliver the safety profile and the safety strategy.

• Assigned compounds will include a variety obesity/metabolism products in various stages of development.

• This position requires the ability to work with and influence colleagues in a matrix environment within and external to GPS including senior management.

• 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, General Medicine

• 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 ICASRs, 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

• 5+ years of total relevant experience in PV and/or relevant medical field with Pharm
  
  D / PhD / MD degree

• 15+ years of total relevant experience in PV and/or relevant medical field or equivalent in lieu 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)

• Demonstrated experience in specialty TAs incorporating advanced therapies, such as gene therapy into pharmacovigilance practices

• 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.

• Thorough understanding of drug development and context as applicable to safety surveillance activities

• 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.

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