Director, Clinical Monitoring Oversight

Olema Oncology•San Francisco, CA

8h•$235,000 - $250,000•Hybrid

About The Position

Olema Oncology is seeking a Director, Clinical Monitoring Oversight to provide strategic and operational leadership for global clinical monitoring oversight across Olema’s clinical programs. This role ensures that clinical monitoring, whether by internal teams, through Functional Service Providers (FSPs), or outsourced to Clinical Research Organizations (CROs), is executed with high standards of quality and consistency while maintaining compliance with GCP regulations. The Director oversees Olema’s Clinical Monitoring Oversight Leads, regional monitoring and oversight teams, clinical service provider/FSP provider, and site performance. This role will develop and implement global monitoring oversight strategies and standards for Olema’s clinical monitoring execution, driving operational excellence, data integrity, and inspection readiness across all trials with an emphasis on risk-based, data driven processes. The role will adapt to evolving organizational structures, monitoring delivery models, and clinical development needs as Olema's portfolio and operational requirements change. This role is based out of our San Francisco or Cambridge office and will require 10-20% travel.

Requirements

Bachelors/Masters 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+ years of clinical operations experience
Minimum 5 years direct site monitoring experience preferred
Minimum 5 years in a role providing oversight of global monitoring activities and FSP/CRO management preferred
3+ years of demonstrated direct people management experience, including performance management, coaching, and staff development
Oncology experience required
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
Experience with monitoring resource planning, vendor budgets, and resource utilization preferred
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 with high accountability
Ability to drive consistency and quality across complex global programs

Nice To Haves

Minimum 5 years direct site monitoring experience
Minimum 5 years in a role providing oversight of global monitoring activities and FSP/CRO management
Experience with monitoring resource planning, vendor budgets, and resource utilization

Responsibilities

Provide strategic direction and operational oversight of all global monitoring activities across Olema’s clinical programs
Oversee internal clinical monitoring and/or oversight team and FSP vendor responsible for providing Clinical Oversight Monitors (COMs) and/or Clinical Research Associates, ensuring alignment, consistency, and accountability across global regions
Adapt clinical monitoring and oversight strategies, organizational structures, resource allocation, and operating models to meet evolving clinical development and business needs
Oversee clinical monitoring and/or monitoring oversight resource planning, utilization, and related budgets and forecasts, ensuring alignment with study priorities, risk, workload, and portfolio needs
Establish and maintain effective governance with the FSP partner, including performance management, risk mitigation, and continuous improvement in monitoring quality and efficiency
In collaboration with assigned Clinical Trial Leads, define and implement Olema’s clinical monitoring and oversight strategy, including risk-based and centralized monitoring approaches in alignment with ICH-GCP and regulatory expectations
Ensure global harmonization of clinical monitoring and oversight 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 Compliance, Clinical Quality, Pharmacovigilance, Clinical Science, 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 and oversight staff, fostering collaboration, accountability, and continuous improvement
Support organizational capability development, succession planning, and evolving staffing needs to ensure effective monitoring and oversight as the clinical portfolio changes
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
Establish and implement monitoring oversight reporting processes, tools, and communication pathways to ensure COMLs provide timely, consistent, and actionable updates to Clinical Trial Leads (CTLs), enabling effective collaboration, risk escalation, and CTL accountability for monitoring quality and performance within their assigned trials
May perform the full scope of Clinical Oversight Monitor Lead (COML) responsibilities, including direct oversight of assigned COMs, sites and CRAs, as needed based on study requirements, resource availability, and/or organizational priorities