Director, Clinical Monitoring Oversight

About the Role >>> Director, Clinical Monitoring Oversight

As the Director, Clinical Monitoring Oversight, reporting to the Senior Director, Clinical Operations, you will provide strategic and operational leadership for global clinical site monitoring activities across Olema's clinical programs. You will ensure 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. You will oversee Olema's Clinical Monitoring Oversight Leads, regional monitoring teams, and site performance. As the Director, Clinical Monitoring Oversight, you will develop and implement monitoring oversight strategies and standards for Olema's clinical monitoring execution worldwide-driving operational excellence, data integrity, and inspection readiness across all trials with an emphasis on risk-based, data driven processes.

This role is based out of either our Boston, MA or San Francisco, CA office and will require about travel 15% travel.

Your work will primarily encompass:

• 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

Ideal Candidate Profile >>>

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.

Knowledge:

• Bachelor's or Master's degree in a scientific discipline or a related scientific field is required
• 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 (qualification, initiation, interim, and close-out visits) with strong understanding of site operations and clinical trial execution
• Minimum 5 years in a role providing global monitoring oversight, including oversight of clinical site monitors, FSP/CRO management and oversight, monitoring quality metrics, KPIs, and governance, and a track record of driving performance improvement and corrective action plans
• Experience overseeing regional monitoring functions and ensuring alignment across geographically distributed teams
• Oncology experience is required

Attributes:

• Demonstrated ability to manage FSP or CRO partnerships, including contract governance, KPI development, and issue escalation
• Skilled in risk-based monitoring methodologies and the use of oversight tools and systems
• Strategic thinker with excellent communication, leadership, and interpersonal skills, with the ability to influence cross-functionally and externally
• Strong analytical and problem-solving abilities; adept at managing competing priorities in a fast-paced environment

The base pay range for this position is expected to be $235,000 - $250,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

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