Senior Director, Safety Sciences - Oncology Pharmacovigilance

Olema Oncology; Cambridge (MA); On-site; USD 270,000 - 310,000; Full time

Benefits offered by this job

Equity

Bonus

Benefits package

Summary of Benefits

Job summary

Olema Oncology is seeking a Senior Director of Safety Sciences to lead the safety science function and provide strategic leadership across safety activities within our growing oncology portfolio. The role focuses on integrating safety considerations into program strategy and working closely with clinical development, regulatory, and medical affairs.

The position reports to the Vice President of Drug Safety and Pharmacovigilance, leads a high-performing team, and will be based in San Francisco or

Qualifications

• MD/PhD/PharmD or MD-equivalent degree required.
• At least 15 years in drug safety in biopharma.
• Minimum 6+ years of people leadership experience.
• Experience in oncology and small molecule programs preferred.
• Strong knowledge of ICH, FDA, and EU regulations governing patient safety.

Responsibilities

• Lead strategic planning of patient safety activities across development programs.
• Oversee safety document development (DSURs, ISS, regulatory submissions, and related documents).
• Review SAEs, SUSARs, and signal detection activities; ensure accuracy of narratives and coding.
• Provide safety input in Data Monitoring Committee meetings and safety data interpretation.
• Ensure quality systems, audits, inspection readiness, and regulatory inspections readiness.
• Develop and deliver safety training for staff and cross-functional partners.
• Build and mentor a high-performing Safety Sciences team and manage capacity and performance.

Skills

Pharmacovigilance

Drug safety leadership

Signal detection

Regulatory submissions

Oncology experience

Education

MD/PhD/PharmD or MD equivalent

Job description

Olema Oncology is seeking a Senior Director of Safety Sciences to lead the safety science function and provide strategic leadership across safety activities within our growing oncology portfolio. The role focuses on integrating safety considerations into program strategy and working closely with clinical development, regulatory, and medical affairs.

The position reports to the Vice President of Drug Safety and Pharmacovigilance, leads a high-performing team, and will be based in San Francisco or