Reporting to the Global Patient Safety (GPS) Therapeutic Area (TA) Head of General Medicines, the Senior Director plays a critical role in contributing to Regeneron's gene therapy approach success. This position is the primary contact within the TA for all safety-related issues for the assigned compound(s), focusing on supporting the advancement and commercialization of our gene therapy portfolio.
Key Responsibilities:
* Representing GPS on key product safety governance teams as Chair of the Safety Management Team (SMT) and member of the cross-functional Strategic Program Team (SPT).
* Leading the development of safety strategy, collaborating with stakeholders to deliver the safety profile and strategy.
* Maintaining hands-on knowledge and expertise in monitoring safety of advanced therapies, including biological medicines and gene therapy products.
* Working with and influencing colleagues at all organizational levels, including senior management, in a matrix environment.
Requirements:
* 5+ years of relevant experience in pharmacovigilance and/or medical field with PharmD/PhD/MD degree.
* 15+ years of total relevant experience in PV and/or medical field or equivalent industry experience in drug safety, including PSURs/DSURs/(d)RMPs, or clinical development with demonstrated achievements in safety.
* Demonstrated experience in specialty TAs incorporating advanced therapies, such as gene therapy into pharmacovigilance practices.
* Critical analysis of FDA, EU, and ICH guidelines, initiatives, and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments.
* 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 applicable to safety surveillance activities.
* A proven ability to lead and develop a diverse team of safety professionals in a constructive, goal-oriented environment.
* Ability to work across organizational levels, effectively communicating safety viewpoints and findings.
About the Position:
This Senior Director will be responsible for overseeing all aspects of GPS safety monitoring activities for assigned compounds to drive safety surveillance, signal management, communication of the safety profile, benefit-risk assessment, safety responses to regulatory agency queries, safety documents, and review/provide PV input for clinical documents.