Director, Clinical Monitoring Oversight

Olema Oncology•Boston, MA

About The Position

The Director, Clinical Monitoring Oversight reports to the Vice President, Clinical Operations and provides strategic and operational leadership for global clinical monitoring oversight across Olema’s clinical programs. The role ensures monitoring performed by internal teams, Functional Service Providers (FSPs), and Clinical Research Organizations (CROs) meets consistent quality standards and complies with GCP requirements. It oversees Clinical Monitoring Oversight Leads, regional monitoring and oversight teams, service providers, and site performance. The Director develops and implements global monitoring oversight strategies and standards, emphasizing risk-based, data-driven processes, operational excellence, data integrity, and inspection readiness. The role adapts monitoring strategies, delivery models, organizational structures, and resource plans as the company’s portfolio and operational needs evolve. It is based in either the San Francisco or Cambridge office and requires 10–20% travel. The position leads and mentors internal monitoring and oversight staff, establishes effective FSP governance, collaborates across clinical functions, and represents Monitoring Oversight on cross-functional and governance teams. It may also perform Clinical Oversight Monitor Lead responsibilities, including direct oversight of assigned Clinical Oversight Monitors, sites, and CRAs, as study requirements and organizational priorities require.

Requirements

Bachelor’s or master’s degree in a scientific discipline.
Expert knowledge of global clinical monitoring oversight strategies and execution.
Deep understanding of ICH-GCP, global regulatory requirements, and inspection-readiness expectations.
Strong knowledge of vendor governance models, KPI frameworks, and quality management systems.
Broad understanding of clinical development and cross-functional clinical operations.
12 or more years of clinical operations experience.
Oncology experience.
Significant experience leading global monitoring oversight activities across programs.
Experience managing FSP/CRO partnerships, including governance frameworks and performance management.
Proven track record of driving monitoring quality, operational efficiency, and performance improvement initiatives.
Experience leading teams and developing monitoring oversight capabilities.
Strong strategic thinking and leadership capability.
Excellent communication, influencing, and negotiation skills.
Ability to lead cross-functional initiatives and align stakeholders.
Strong analytical and decision-making ability.
Results-oriented approach and high accountability.
Ability to drive consistency and quality across complex global programs.

Nice To Haves

At least 5 years of direct site monitoring experience.
At least 5 years in a role providing oversight of global monitoring activities and FSP/CRO management.
At least 3 years of demonstrated direct people management experience, including performance management, coaching, and staff development.
Experience with monitoring resource planning, vendor budgets, and resource utilization.

Responsibilities

Provide strategic direction and operational oversight for global monitoring activities across Olema’s clinical programs.
Oversee internal monitoring and oversight teams and FSP vendors providing Clinical Oversight Monitors and/or Clinical Research Associates, ensuring consistency, alignment, and accountability across regions.
Adapt monitoring strategies, organizational structures, resource allocation, and operating models to evolving clinical development and business needs.
Oversee monitoring resource planning, utilization, budgets, and forecasts in alignment with study priorities, risk, workload, and portfolio needs.
Establish and maintain FSP governance, including performance management, risk mitigation, and continuous improvement in monitoring quality and efficiency.
Work with Clinical Trial Leads to define and implement monitoring and oversight strategies, including risk-based and centralized monitoring, consistent with ICH-GCP and regulatory expectations.
Harmonize monitoring and oversight 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 Compliance, Clinical Quality, Pharmacovigilance, Clinical Science, and Clinical Development to align monitoring with program objectives and timelines.
Contribute to developing and reviewing Monitoring Plans, Oversight Plans, Risk Management Plans, and audit and inspection responses.
Assess monitoring risks and implement mitigation strategies to maintain inspection readiness.
Lead, manage, and mentor monitoring and oversight staff, fostering collaboration, accountability, and continuous improvement.
Support organizational capability development, succession planning, and evolving staffing needs.
Represent Monitoring Oversight on cross-functional and governance teams, presenting program updates, risks, and mitigation strategies to senior management.
Drive innovation and process optimization, including the use of technology and data analytics to improve monitoring quality and efficiency.
Establish reporting processes, tools, and communication pathways so COMLs provide timely, consistent, actionable updates to Clinical Trial Leads and support risk escalation and accountability.
As needed, perform Clinical Oversight Monitor Lead responsibilities, including direct oversight of assigned COMs, sites, and CRAs.