Director, Clinical Operations

The Position At Maze Therapeutics, we believe precision medicine has the power to transform the lives of patients with both common and rare diseases. As Director of Clinical Operations, you will serve as Study Lead for a complex, global pivotal Phase 3 program within our chronic kidney disease (CKD) clinical development portfolio. You will be responsible for end-to-end study execution, working closely with cross-functional colleagues and external partners to translate development strategy into a practical study plan and deliver the study with quality, efficiency, and operational excellence. Working closely with the study team, you will guide the Study Execution Team (SET), combining strategic oversight with hands-on execution to support successful trial delivery. This role requires someone who can synthesize complex information, anticipate challenges, facilitate cross-functional problem-solving, support timely decisions, and help teams identify the most effective path forward. In partnership with the Oversight Director, you will support and develop a high-performing study team, oversee CRO and vendor activities, manage a substantial global study budget, and maintain continuous inspection readiness. The successful candidate will thrive in a collaborative biotech environment and bring the flexibility, adaptability, and sound judgment needed to respond to evolving data and program priorities while maintaining clarity, accountability, and focus on study objectives. The Impact You’ll Have Global Phase 3 Study Leadership Serve as the operational Study Lead for a global pivotal Phase 3 study (North America, South America, Africa, and Europe), maintaining responsibility for successful execution from protocol development and start-up through enrollment, database lock, study closeout, submission support, and inspection readiness. Act as the operational steward of the protocol, translating requirements into executable plans, keeping oversight of key study quality indicators such as operational performance, site trends, data quality, IP handling, etc. through identification/mitigation of emerging risk. Establish and proactively monitor key study milestones including FPI, feasibility, enrollment, site activation, interim analyses, database lock, and CSR delivery, utilizing data-informed forecasting and risk mitigation approaches. Support, coach, and develop Clinical Operations team members while coordinating a large cross-functional study team; establish clear expectations, encourage professional growth, and promote shared accountability for study outcomes. Delegate responsibilities with clear ownership, timelines, and decision authority, and work with the Oversight Director to align resources with evolving study needs. Vendor, CRO & Site Management Oversee global CRO, vendor, and site strategies, including selection, governance, performance metrics, risk management approaches, escalation pathways, and corrective action planning. Facilitate strategic discussions with CROs and vendors regarding master service agreements, study budgets, and scope modifications. Serve as the primary operational escalation resource for CRO, vendor, and site performance concerns. Participate in governance and partnership discussions with external service providers as needed. Budget & Financial Oversight Maintain accountability for a large global Phase 3 study budget, including forecasting, accruals, variance analysis, scope management, change control, and long-range planning. Data Quality, Compliance & Regulatory Readiness Maintain a continuous state of inspection readiness across the study, including safety reporting, TMF completeness and quality, essential documentation, evidence of vendor oversight, issue and CAPA management, and audit preparedness, in close partnership with Quality Assurance (QA). Collaborate with QA and Oversight Director on the study's operational compliance strategy, ensuring adherence to SOPs, ICH-GCP, and global regulatory requirement…