Global Patient Safety Director - Strategy & Leadership

BioSpace; Cambridge (MA); On-site; USD 205,000 - 342,000; Full time

Job summary

Regeneron is seeking a Director of Global Patient Safety to lead safety strategy for assigned assets and to serve as the GPS representative on cross-functional programs. This role requires influencing stakeholders in a matrix environment and coordination with external partners to drive pharmacovigilance across development and commercialization.

The position focuses on safety surveillance, signal management, regulatory communications, and the development of safety documents while mentoring a

Qualifications

• Minimum 10+ years of total relevant experience in PV and/or relevant medical field or equivalent 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).
• 5+ years of total relevant experience in PV and/or relevant medical field with PharmD / PhD / MD degree required.
• Clinical experience and/or industry experience in Oncology is a plus.

Responsibilities

• 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 complex ICRS, 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
• 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 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.

Skills

PV leadership

Cross-functional leadership

Regulatory knowledge

Safety strategy

Education

PharmD

PhD

MD

Job description

Regeneron is seeking a Director of Global Patient Safety to lead safety strategy for assigned assets and to serve as the GPS representative on cross-functional programs. This role requires influencing stakeholders in a matrix environment and coordination with external partners to drive pharmacovigilance across development and commercialization.

The position focuses on safety surveillance, signal management, regulatory communications, and the development of safety documents while mentoring a