Director, Safety Sciences — Regulatory Safety Leader

Olema Oncology; Boston (MA); On-site; USD 235,000 - 255,000; Full time

Benefits offered by this job

Competitive compensation

Flexible work environment

Career development support

Job summary

Olema Oncology is looking for a Director, Safety Sciences, responsible for leading clinical safety data strategy and ensuring compliance for global regulatory submissions.

This role involves preparing safety components for NDA/BLA filings and conducting benefit-risk assessments. Candidates should have significant experience in pharmacovigilance, particularly in oncology, and possess strong analytical and communication skills.

The position is based in Boston or San Francisco with a base salary range of $235,000‑$255,000 annually, along with equity and benefits.

Qualifications

• 8+ years in pharmacovigilance/drug safety in biopharma (MD, PhD, PharmD), or 10+ years for RN.
• Late-phase clinical development experience with NDA/BLA submissions.
• Familiarity with FDA, EU, ICH guidelines, and pharmacovigilance regulations.

Responsibilities

• Lead preparation of safety components for NDA/BLA submissions.
• Conduct comprehensive evaluation of safety data from clinical studies.
• Collaborate with multiple teams to develop safety strategies.

Skills

Pharmacovigilance

Oncology background

Strong verbal and written communication

Analytical skills

Education

MD, PhD, PharmD, or RN degree

Job description

Olema Oncology is looking for a Director, Safety Sciences, responsible for leading clinical safety data strategy and ensuring compliance for global regulatory submissions.

This role involves preparing safety components for NDA/BLA filings and conducting benefit-risk assessments. Candidates should have significant experience in pharmacovigilance, particularly in oncology, and possess strong analytical and communication skills.

The position is based in Boston or San Francisco with a base salary range of $235,000‑$255,000 annually, along with equity and benefits.