Director, Clinical Monitoring Oversight
Scorpion Therapeutics, Cambridge, Massachusetts, us, 02140
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
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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
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