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Salary: USD 270,000 - 310,000 / annual
Olema Oncology, a clinical-stage biopharmaceutical company focused on transforming oncology treatment, is seeking a Senior Director of Patient Safety Sciences to lead and build the company's Safety Science function. You will report to the VP of Drug Safety and Pharmacovigilance and serve as a trusted safety science expert providing strategic and scientific leadership across Olema's growing development portfolio.
Key Responsibilities:
- Lead strategic planning and execution of patient safety activities, including pharmacovigilance and risk-management strategies, signal detection, assessment, and evaluation.
- Develop and author safety-related sections of clinical and regulatory documents including benefit-risk assessments, protocols, Investigator's Brochures, informed consent forms, and regulatory submissions.
- Provide clinical and medical review of serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs), including source record review, MedDRA coding evaluation, and determination of expectedness and reportability.
- Lead safety expertise in Data Monitoring Committee meetings, preparing and interpreting relevant safety data.
- Oversee quality systems, audits, inspection readiness, and regulatory inspections to maintain compliance and preparedness.
- Develop and deliver safety-related training for employees, cross-functional partners, and clinical site personnel.
- Build, lead, and develop a high-performing Safety Sciences team, providing coaching, mentorship, and fostering accountability and continuous improvement.
- Assess organizational capabilities and resource requirements, identifying talent and capacity needs to support the evolving portfolio.
The role is based in San Francisco or Boston with minimal travel required.
Requirements:
- MD, PhD, PharmD, or equivalent from accredited institution.
- Minimum 15 years of relevant experience in drug safety in the biopharmaceutical industry, specifically in oncology clinical trials.
- Minimum 6+ years of progressive people leadership experience, including managing, developing, and mentoring high-performing teams.
- Oncology experience required; small molecule experience preferred.
- Strong knowledge of ICH, FDA, and EU regulations and guidelines governing patient safety and pharmacovigilance.
- Experience with registrational clinical development programs and filings.
- Demonstrated expertise in signal detection, benefit-risk evaluation, and pharmacovigilance throughout the product lifecycle.
- Track record of supporting and leading pharmacovigilance audits and regulatory inspections.
- Experience selecting, managing, and overseeing safety and pharmacovigilance vendors.
- Proven capability to lead through organizational growth and change, establish priorities, and work independently with sound judgment.
- Excellent verbal and written communication skills with ability to communicate complex safety information to diverse audiences.
- Strong commitment to scientific rigor, quality, compliance, and operational excellence.
- Impeccable professional ethics, integrity, and judgment.
