Senior Director, Patient Safety Sciences: Strategic Safety

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

Benefits offered by this job

Equity

Bonus potential

Benefits

Job summary

Olema Oncology is seeking a Senior Director, Patient Safety Sciences to lead and strengthen our Safety Sciences function. You will provide strategic safety leadership across the development portfolio, oversee a high-performing team, and ensure safety considerations are embedded in program strategy and regulatory submissions.

You will manage safety reviews, SAEs/SUSARs analyses, and drive pharmacovigilance excellence, audits, and vendor oversight, while advancing patient safety and regulatory

Qualifications

• MD/PhD/PharmD with oncology pharmacovigilance experience.
• Minimum 15 years in drug safety within biopharmaceuticals.
• 6+ years of progressive people leadership experience.
• Experience with regulatory submissions and DSURs.
• Strong strategic safety and risk-management expertise.

Responsibilities

• Lead safety activities across Olema’s portfolio with cross-functional collaboration.
• Develop and author safety sections of clinical/regulatory documents (ISRs, DSURs, FBRs, ICFs, etc.).
• Review SAEs, SUSARs, and related analyses; ensure accurate source data and MedDRA coding.
• Provide safety leadership in Data Monitoring Committee meetings and safety data interpretation.
• Lead quality systems, audits, inspection readiness, and regulatory inspections within Safety Sciences.
• Develop and deliver safety training for employees and site personnel.
• Build, coach, and mentor a high-performing Safety Sciences team; manage goals and workloads.
• Assess capabilities and resources for Safety Sciences to support portfolio growth.

Skills

Leadership

Pharmacovigilance

Oncology

Medical review

Regulatory knowledge

Education

MD/PhD/PharmD or MD equivalent

Job description

Olema Oncology is seeking a Senior Director, Patient Safety Sciences to lead and strengthen our Safety Sciences function. You will provide strategic safety leadership across the development portfolio, oversee a high-performing team, and ensure safety considerations are embedded in program strategy and regulatory submissions.

You will manage safety reviews, SAEs/SUSARs analyses, and drive pharmacovigilance excellence, audits, and vendor oversight, while advancing patient safety and regulatory