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Senior Director, Global Patient Safety
7 months ago
Reporting to the Global Patient Safety (GPS) Therapeutic Area (TA) Head of General Medicines, the Senior Director is a key role that contributes to the success of Regeneron’s novel gene therapy approach. This position serves as the primary contact within the TA for all safety-related issues for the assigned compound(s) focusing mainly on supporting the advancement and commercialization of our gene therapy portfolio.
In this role, a typical day might include:
Representing GPS on key product safety governance teams as Chair of the Safety Management Team (SMT) and a member of the cross-functional Strategic Program Team (SPT). The incumbent leads the development of safety strategy, collaborates to ensure optimal support from within GPS and with cross-functional stakeholders to deliver the safety profile and the safety strategy. This position employs hands-on knowledge and proven expertise monitoring safety of advanced therapies including biological medicines and gene therapy products. This position requires the ability to work with and influence colleagues of all organizational levels, including senior management, in a matrix environment.
This role might be for you if can:
Serve with direct responsibility for overseeing all aspects of GPS safety monitoring activities for assigned compounds (primarily gene therapy) to drive 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, RMPs, etc.) and review / provide PV input for clinical documents (Investigator Brochures, protocols, clinical study reports, and other relevant study documents)
Lead cross-functional meetings including 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)
Serve as delegate for GPS Therapeutic Area Head of General Medicines (GM), as needed
Help to evolve the GPS methods to cover gene therapies and advanced technologies.
Proactively identify and develop safety strategies and planning for non-compound specific GPS activities (e.g., mechanism of action)
Act as a resource for medical review for complex 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 cultivating cross functional relationships and mentoring junior safety scientists
To be considered for this opportunity, you must have the following:
5+ years of total relevant experience in PV and/or relevant medical field with PharmD / PhD / MD degree
15+ 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)
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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