Senior Director of Safety Science & Pharmacovigilance

Generate:Biomedicines; Somerville (MA); On-site; USD 150,000 - 200,000; Full time

Job summary

Generate:Biomedicines is seeking a Senior Director of Safety Science to provide strategic leadership across its clinical-stage portfolio. This role requires a deep understanding of pharmacovigilance and strong clinical judgment, influencing stakeholders without direct authority.

The ideal candidate will have significant experience in drug safety, overseeing safety governance activities, and contributing to regulatory submissions. This position offers the opportunity to shape safety standards and operational excellence.

Qualifications

• Minimum of 12 years of experience in drug safety/pharmacovigilance.
• Strong experience supporting products across multiple stages of development.
• Demonstrated ability to operate with broad autonomy and prioritize.

Responsibilities

• Provide strategic leadership for safety science across assigned development programs.
• Shape the safety strategy for products in clinical development.
• Drive high-quality interpretation of safety data from multiple sources.

Skills

Clinical judgment

Influencing stakeholders

Signal detection

Pharmacovigilance regulations knowledge

Education

MD, DO or equivalent

Formal training in patient care

Tools

Argus

Veeva Safety

Spotfire

Job description

Generate:Biomedicines is seeking a Senior Director of Safety Science to provide strategic leadership across its clinical-stage portfolio. This role requires a deep understanding of pharmacovigilance and strong clinical judgment, influencing stakeholders without direct authority.

The ideal candidate will have significant experience in drug safety, overseeing safety governance activities, and contributing to regulatory submissions. This position offers the opportunity to shape safety standards and operational excellence.