Director, Global Patient Safety Strategy & Leadership

BioSpace; Cambridge (MA); On-site; USD 180,000 - 260,000; Full time

Job summary

Regeneron is seeking a Director to join the Global Patient Safety team, leading safety strategy and collaboration across a matrix organization. This role acts as the GPS representative on strategic programs and interacts with senior management to ensure patient safety throughout the asset lifecycle.

The Director will manage safety surveillance, DSUR/PSUR content, and regulatory responses, while mentoring junior safety scientists and contributing to SOP development and continuous improvement.

Qualifications

• Total PV/medical field experience advised (10+ years).
• Experience with PSURs/DSURs/RMPs and CSR content is preferred.
• Oncology experience is a plus.

Responsibilities

• Direct Global Patient Safety (GPS) activities for assigned compounds, including safety surveillance and signal management.
• Lead cross-functional Safety Monitoring Team (SMT) activities and represent GPS on cross-functional teams (RSOC, IDMC, SPT).
• Proactively develop safety strategies for non-compound-specific GPS activities and mechanism of action work.
• Act as medical review resource for complex ICsrs and other data sources.
• Participate in SOPs, practices, and guides development and maintenance.

Skills

Safety leadership

Cross-functional collaboration

Regulatory knowledge

Mentoring

Medical review

Education

PharmD

PhD

MD

Job description

Regeneron is seeking a Director to join the Global Patient Safety team, leading safety strategy and collaboration across a matrix organization. This role acts as the GPS representative on strategic programs and interacts with senior management to ensure patient safety throughout the asset lifecycle.

The Director will manage safety surveillance, DSUR/PSUR content, and regulatory responses, while mentoring junior safety scientists and contributing to SOP development and continuous improvement.