Director, Clinical Monitoring Oversight

Role Summary

Direct and oversee global clinical site monitoring across Olema’s clinical programs, ensuring high-quality, compliant monitoring activities whether conducted by internal teams, FSPs, or CROs. Responsible for strategy, governance, and performance of monitoring activities, driving data integrity, inspection readiness, and operational excellence in a risk-based, data-driven framework. Based in Boston, MA or San Francisco, CA with travel expectations around 15%.

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 responsible for providing Regional Site Monitoring Leads (RSMLs), ensuring alignment, consistency, and accountability across global regions
• Establish and maintain effective governance with the FSP partner, including performance management, risk mitigation, and continuous improvement in monitoring quality and efficiency
• Define and implement Olema’s 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 key performance indicators (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 ensure monitoring activities are aligned 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: Required: 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: Required: Minimum 12 years of clinical operations experience in pharma/biotech; minimum 5 years direct site monitoring experience with site operations and trial execution; minimum 5 years in global monitoring oversight including oversight of monitors, FSP/CRO management, monitoring quality metrics, KPIs, and governance; proven track record of performance improvement and corrective action; regional monitoring experience; oncology experience
• Attributes: Required: Demonstrated ability to manage FSP or CRO partnerships with contract governance, KPI development, and issue escalation; risk-based monitoring expertise and use of oversight tools; strategic thinker with strong communication, leadership, and interpersonal skills; strong analytical and problem-solving abilities with ability to manage competing priorities in a fast-paced environment

Education

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

Additional Requirements

• 15% travel required
• Based in Boston, MA or San Francisco, CA