Director, Clinical Monitoring Oversight

Role Summary

Director, Clinical Monitoring Oversight provides strategic and operational leadership for global clinical site monitoring across Olema’s clinical programs, ensuring high-quality, compliant monitoring whether performed in-house, via FSPs, or through CROs. The role oversees monitoring leads, regional teams, and site performance; develops worldwide monitoring strategies and standards; and drives risk-based, data-driven processes to maintain inspection readiness and data integrity.

Responsibilities

• Provide strategic direction and operational oversight of all global monitoring activities across Olema’s clinical programs
• Oversee internal clinical monitoring oversight team and FSP vendor providing Regional Site Monitoring Leads (RSMLs), ensuring alignment, consistency, and accountability across global regions
• Establish and maintain governance with the FSP partner, including performance management, risk mitigation, and continuous improvement in monitoring quality and efficiency
• Define and implement monitoring strategy, including risk-based and centralized monitoring approaches in alignment with ICH-GCP and regulatory expectations
• Ensure global harmonization of clinical monitoring processes, training, and documentation across programs and regions
• Develop and monitor KPIs and quality metrics to evaluate site performance, FSP delivery, and regional oversight effectiveness
• Collaborate with Clinical Operations, Data Management, Clinical Quality, and Clinical Development to align monitoring activities with program objectives and timelines
• Contribute to the development and review of key operational documents, including Monitoring Plans, Oversight Plans, Risk Management Plans, and audit/inspection responses
• Proactively assess monitoring risks and implement mitigation strategies to maintain inspection readiness
• Lead, manage, and mentor internal monitoring oversight staff, fostering collaboration, accountability, and continuous improvement
• Serve as the Monitoring Oversight representative on cross-functional and governance teams, presenting program updates, risks, and mitigation strategies to senior management
• Drive innovation and process optimization in monitoring oversight practices, including leveraging technology and data analytics to enhance quality and efficiency

Qualifications

• Knowledge: Bachelor's or Master’s degree in a scientific discipline or related field; strong understanding of ICH-GCP, FDA, EMA, and other global regulatory requirements related to monitoring and clinical trial conduct
• Experience: Minimum 12 years of clinical operations experience in the pharmaceutical or biotech industry; minimum 5 years direct site monitoring experience; minimum 5 years in a global monitoring oversight role including oversight of site monitors, FSP/CRO management, monitoring quality metrics, KPIs, and governance; oncology experience required
• Attributes: Demonstrated ability to manage FSP or CRO partnerships with contract governance, KPI development, and issue escalation; skilled in risk-based monitoring methodologies and oversight tools; strategic thinker with strong communication, leadership, and interpersonal skills; strong analytical and problem-solving abilities and ability to manage conflicting priorities in a fast-paced environment

Education

• Bachelor's or Master’s degree in a scientific discipline or related field

Additional Requirements

• Travel: approximately 15% travel