Director, Safety Sciences — Regulatory Safety Leader

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

Benefits offered by this job

Competitive compensation and benefits

Flexible work environment

Career development opportunities

Job summary

Olema Oncology in Cambridge is seeking a Director, Safety Sciences to lead safety data strategy across clinical development. The ideal candidate will have over 8 years of pharmacovigilance experience, strong knowledge of FDA regulations, and excellent communication skills.

This role entails preparing safety components for regulatory submissions, conducting benefit-risk assessments, and collaborating with various teams. A competitive salary, equity, and benefits are offered within a supportive work environment.

Qualifications

• Minimum 8+ years of experience in pharmacovigilance or drug safety in the biopharmaceutical industry.
• Experience with NDA/BLA submissions and late-phase clinical development.
• Strong background in regulatory compliance and benefit-risk assessments.

Responsibilities

• Lead the preparation of safety components for NDA/BLA submissions.
• Conduct comprehensive evaluations of clinical safety data.
• Collaborate with cross-functional teams for regulatory submissions.

Skills

Pharmacovigilance experience

Regulatory submissions

Clinical development

Analytical skills

Communication skills

Education

MD, PhD, PharmD or RN degree

Tools

Clinical database / EDC

CTD/eCTD

Job description

Olema Oncology in Cambridge is seeking a Director, Safety Sciences to lead safety data strategy across clinical development. The ideal candidate will have over 8 years of pharmacovigilance experience, strong knowledge of FDA regulations, and excellent communication skills.

This role entails preparing safety components for regulatory submissions, conducting benefit-risk assessments, and collaborating with various teams. A competitive salary, equity, and benefits are offered within a supportive work environment.