Director, Clinical Monitoring Oversight

Olema Oncology•Boston, MA

8h•$235,000 - $250,000

About The Position

The Director, Clinical Monitoring Oversight provides strategic and operational leadership for global clinical monitoring oversight across Olema’s clinical programs. Reporting to the Vice President, Clinical Operations, this role ensures monitoring performed by internal teams, Functional Service Providers (FSPs), or Clinical Research Organizations (CROs) meets high standards of quality and consistency and complies with GCP regulations. The Director oversees Clinical Monitoring Oversight Leads, regional monitoring and oversight teams, clinical service providers, and site performance. The role develops and implements global monitoring oversight strategies and standards, promoting operational excellence, data integrity, and inspection readiness through risk-based, data-driven processes. It adapts strategies, organizational structures, delivery models, and resource allocation to changing clinical development and business needs. The position is based in either Olema’s San Francisco or Cambridge office and requires 10–20% travel.

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.
At least 3 years of demonstrated direct people management experience, including performance management, coaching, and staff development.
Oncology experience.
Significant experience leading global monitoring oversight activities across programs.
Experience managing FSP/CRO partnerships, including governance frameworks and performance management.
Proven 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 overseeing global monitoring activities and FSP/CRO management.
Experience with monitoring resource planning, vendor budgets, and resource utilization.

Responsibilities

Provide strategic direction and operational oversight for global monitoring activities across clinical programs.
Oversee internal monitoring and oversight teams and FSP vendors supplying Clinical Oversight Monitors (COMs) and/or Clinical Research Associates, ensuring alignment, consistency, and accountability across regions.
Adapt monitoring strategies, organizational structures, resource allocation, and operating models to meet 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 partner governance, including performance management, risk mitigation, and continuous improvement in monitoring quality and efficiency.
Collaborate with Clinical Trial Leads to define and implement monitoring and oversight strategies, including risk-based and centralized monitoring approaches aligned with ICH-GCP and regulatory expectations.
Harmonize monitoring and oversight processes, training, and documentation across programs and global regions.
Develop and monitor KPIs and quality metrics for 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 activities with program objectives and timelines.
Contribute to operational documents, including 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 staffing needs as the clinical portfolio changes.
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 use of technology and data analytics to improve monitoring quality and efficiency.
Establish monitoring oversight reporting processes, tools, and communication pathways so COMLs provide timely, consistent, actionable updates to Clinical Trial Leads and support risk escalation and accountability for monitoring quality and performance.
Perform the full scope of Clinical Oversight Monitor Lead responsibilities, including direct oversight of assigned COMs, sites, and CRAs, as needed based on study requirements, resource availability, or organizational priorities.