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Salary: USD 270,000 - 310,000 / annual
Olema Oncology is a clinical-stage biopharmaceutical company developing innovative therapies for breast cancer and other oncology indications. The company's lead candidate, palazestrant, is a novel estrogen receptor antagonist in two pivotal Phase 3 trials with top-line data expected in Q1 2027.
As Senior Director of Patient Safety Sciences, you will report to the VP of Drug Safety and Pharmacovigilance and lead the strategic planning and execution of Olema's patient safety function. You will build and develop a high-performing Safety Sciences team, establish priorities, and foster a culture of accountability and continuous learning.
Key responsibilities include:
- Leading strategic planning and execution of patient safety activities across the development portfolio, including pharmacovigilance and risk-management strategies
- Leading development and authoring of safety-related sections of clinical and regulatory documents (protocols, Investigator's Brochures, informed consent forms, benefit-risk assessments, core safety information)
- Providing 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
- Providing safety expertise and leadership in Data Monitoring Committee meetings
- Leading Safety Sciences activities related to quality systems, audits, inspection readiness, and regulatory inspections
- Developing and delivering safety-related training for employees, cross-functional partners, and clinical site personnel
- Building, leading, and developing a high-performing team with coaching, mentorship, goal-setting, and performance management
- Assessing organizational capabilities and resource requirements for the Safety Sciences function
- Representing Olema's safety perspective in engagements with investigators, partners, and regulatory agencies
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
- Comprehensive understanding of the pharmaceutical industry and emerging trends in drug safety
- Experience with registrational clinical development programs and filings
- Track record of strong individual performance combined with demonstrated success in building and leading high-performing teams
- Demonstrated ability to coach and develop employees, establish clear expectations, manage performance, and foster collaboration and accountability
- Experience selecting, managing, and overseeing safety and pharmacovigilance vendors
- Experience providing strategic safety input into clinical study activities, regulatory submissions, DSURs, Integrated Summaries of Safety (ISS), responses to regulatory inquiries, pharmacovigilance processes, and risk management plans
- Demonstrated expertise in signal detection and benefit-risk evaluation throughout the product lifecycle
- Track record of supporting and leading pharmacovigilance audits and regulatory inspections
- Proven capability to lead through organizational growth and change
- Experience establishing and implementing best practices that strengthen quality, compliance, and operational effectiveness
- Proven track record of working independently, establishing priorities, and delivering results with minimal guidance
- Excellent verbal and written communication skills with ability to communicate complex safety information to diverse audiences
- Strategic and proactive leadership with strength in setting direction, evaluating priorities, and building effective partnerships
- Strong commitment to scientific rigor, quality, compliance, and operational excellence
- Self-motivated, adaptable, and enthusiastic with ability to learn quickly and adjust direction in a fast-paced environment
- Impeccable professional ethics, integrity, and judgment
