Director, Clinical Monitoring Oversight

Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with best-in-class potential.

Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another. At Olema, we know that when we put people first, our work becomes second to none. If you’re ready to join us at the edge of something unstoppable, let’s make a profound impact together for our patients, for your career, for what’s beyond.

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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 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

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…