Director, Global Patient Safety – Oncology Strategy

Regeneron Pharmaceuticals, Inc.; Cambridge (MA); Hybrid; USD 190,000 - 230,000; Full time

Benefits offered by this job

Medical, dental and vision insurance

Life insurance and disability coverage

Global wellness support & benefits

Paid time off, personal/flexibility

Job summary

Regeneron Pharmaceuticals, Inc. in the United States seeks a Director to leadGlobal Patient Safety Sciences in oncology. You will guide safety surveillance, risk assessment, and regulatory responses for assigned assets, working with cross-functional teams and external partners.

You will mentor safety professionals, influence in a matrix environment, and contribute to safety strategy across the asset lifecycle in a fast-growing, science-driven organization.

Qualifications

• Minimum 10+ years of total relevant experience in PV and/or relevant medical field or equivalent industry experience in drug safety including significant experience with PSURs/DSURs/(d) RMPS; or in clinical development with demonstrated achievements in safety.
• 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

• Lead safety strategy and ensure optimal support from GPS for assigned compounds.
• Represent GPS on cross-functional teams such as RSOC, IDMC, SPT and alliance partners.
• Develop safety planning for non-compound specific GPS activities and provide medical review for complex data.
• Contribute to SOPs, working practices and continuous improvement within GPS and TA.
• Mentor junior safety scientists and communicate safety viewpoints across organizational levels.
• Apply FDA, EU and ICH guidelines to pharmacovigilance in clinical trials and post-marketing contexts.

Skills

PV experience

Cross-functional collaboration

Leadership

Education

PharmD / PhD / MD

Job description

Regeneron Pharmaceuticals, Inc. in the United States seeks a Director to leadGlobal Patient Safety Sciences in oncology. You will guide safety surveillance, risk assessment, and regulatory responses for assigned assets, working with cross-functional teams and external partners.

You will mentor safety professionals, influence in a matrix environment, and contribute to safety strategy across the asset lifecycle in a fast-growing, science-driven organization.