Senior Director, Patient Safety Sciences

About the Role >>> Senior Director, Patient Safety Sciences

As the Senior Director of Safety Sciences, you will report to the Vice President, Drug Safety and Pharmacovigilance and play a critical leadership role in building and strengthening Olema’s Safety Science function. As a trusted safety science expert, you will provide strategic and scientific leadership for the planning, implementation, and oversight of patient safety activities across Olema’s growing development portfolio.

You will lead, develop, and inspire a high-performing team, establish clear priorities, strengthening capabilities, and fostering a culture of accountability, collaboration, and continuous learning. Working closely with colleagues across Clinical Development, Regulatory Affairs, Medical Affairs, and other functions, you will ensure that safety considerations are integrated into program strategy and decision-making. You will also represent Olema’s safety perspective in engagements with external stakeholders, including investigators, partners, and regulatory agencies.

This is an opportunity to shape a growing function, develop talented safety professionals, and make a meaningful contribution to the advancement of innovative therapies for patients with cancer.

This role is based out of our San Francisco or Boston office and will require minimal travel.

Your work will primarily encompass:

• Lead the strategic planning and execution of Olema’s patient safety activities, including cross-functional collaboration with key departments. Recommend pharmacovigilance and risk-management strategies and lead signal detection, assessment, and evaluation activities.
• Lead the development and authoring of safety-related sections of clinical and regulatory documents, including benefit-risk assessments, protocols, Investigator’s Brochures, informed consent forms, briefing books, core safety information, and other internal and external documents.
• Provide clinical and medical review of serious adverse events (SAEs), suspected unexpected, serious adverse reactions (SUSARs), and analyses of similar events, as required. Responsibilities include reviewing source records and case narratives for accuracy; evaluating MedDRA coding; identifying medically relevant queries; determining expectedness based on reference safety information; preparing sponsor assessments; and guiding Drug Safety colleagues in determining reportability.
• Provide safety expertise and leadership in Data Monitoring Committee meetings, including the preparation, review, and interpretation of relevant safety data.
• Lead Safety Sciences activities related to quality systems, audits, inspection readiness, and regulatory inspections, ensuring the function maintains a consistent state of compliance and preparedness.
• Develop and deliver safety-related training for employees, cross-functional partners, and clinical site personnel, promoting shared accountability for patient safety and regulatory compliance.
• Build, lead, and develop a high-performing Safety Sciences team. Provide coaching and mentorship to direct reports and junior team members; establish clear goals and expectations; delegate responsibilities effectively; monitor performance and workload; and foster accountability, professional growth, collaboration, and continuous improvement.
• Assess organizational capabilities and resource requirements for the Safety Sciences function, identifying and addressing talent, capacity, and development needs in support of Olema’s evolving portfolio.

Knowledge:

• MD, PhD, PharmD or MD equivalent from accredited institution.
• Strong knowledge of applicable ICH, FDA, and EU regulations and guidelines governing patient safety and pharmacovigilance activities.
• Comprehensive understanding of the pharmaceutical industry, including emerging trends and developments in drug safety and pharmacovigilance.
• Experience with registrational clinical development programs and filings is required.

Experience:

• Minimum of 15 years' relevant experience in drug safety in biopharmaceutical industry and in oncology clinical trials specifically.
• Minimum of 6+ years of progressive people leadership experience, including managing, developing, and mentoring high-performing teams.
• Experience in oncology is required; small molecule experience is preferred.
• Track record of strong individual performance combined with demonstrated success in building, leading, and developing high-performing teams.
• Demonstrated ability to coach and develop employees, establish clear expectations, manage performance, and foster a culture of collaboration, accountability, and continuous learning.
• Demonstrated experience selecting, managing, and overseeing safety and pharmacovigilance vendors, including establishing performance expectations and ensuring quality, compliance, and accountability.
• Experience providing strategic safety input into clinical study activities and documentation, regulatory submissions, Development Safety Update Reports (DSURs), Integrated Summaries of Safety (ISS), responses to regulatory agency inquiries, pharmacovigilance processes and projects, aggregate safety reports, and risk management plans.
• Demonstrated expertise in conducting signal detection and benefit-risk evaluation throughout the product lifecycle.
• Experience in providing strategic input related to safety in product development.
• Track record of supporting and leading pharmacovigilance audits and regulatory inspections.
• Proven capability to lead through organizational growth and change, assume increasing responsibilities as the function evolves, and support the effective integration of activities across teams and functions.
• Experience helping shape departmental goals and objectives, drive process and operational efficiencies, and advance innovative practices within Patient Safety and across the organization.
• Demonstrated experience establishing and implementing best practices that strengthen quality, compliance, operational effectiveness, and continuous improvement within Patient Safety.
• Proven track record of working independently, establishing priorities, exercising sound judgment, and delivering results with minimal guidance.

Attributes:

• Strategic and proactive leader with demonstrated strength in setting direction, evaluating priorities, adapting to change, resolving conflict, and building effective partnerships.
• Excellent verbal and written communication skills, with the ability to communicate complex safety information clearly and effectively to diverse audiences.
• Ability to collaborate and lead effectively in a highly dynamic, science-driven, and cross-functional environment.
• Strong commitment to scientific rigor, quality, compliance, and operational excellence.
• Self-motivated, adaptable, and enthusiastic, with the ability to learn quickly, identify core challenges, and adjust direction as priorities evolve in a fast-paced organization.
• Impeccable professional ethics, integrity, and judgment.

The base pay range for this position is expected to be $270,000-$310,00 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

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