Oversight 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 an Oversight Director, Clinical Operations supporting an asset spanning our CKD and PKU portfolio, you will provide strategic and operational direction across the full development lifecycle. You will be responsible for the successful execution of multiple studies within your assigned program, ensuring high-quality clinical trials are delivered on time, within budget, and in accordance with quality and regulatory expectations. Working closely with the Clinical Science Lead, you will partner in guiding the Clinical Development Sub-Team, providing strategic direction and operational oversight to advance the development program. You will support and develop Study Leads and Clinical Operations team members, establish and oversee CRO and vendor strategies, and maintain accountability for study execution, operational risk management, resource planning, financial oversight, and inspection readiness across your assigned asset. In partnership with the Head of Clinical Operations, you will help shape the operational strategy for your development program, contribute to key development planning, and build cross-functional alignment to enable successful execution from early development through pivotal studies. This role requires a highly collaborative professional who can anticipate challenges, provide thoughtful recommendations, and work effectively across the organization to advance innovative therapies for patients. If you thrive in a fast-paced biotech environment, enjoy developing high-performing teams, and are passionate about operational excellence, this role offers the opportunity to make a meaningful impact on the success of our clinical development programs. The Impact You’ll Have Clinical Development & Portfolio Collaboration Provide strategic and operational direction across an assigned development asset spanning CKD and PKU clinical programs, ensuring alignment between clinical development strategy and operational execution from protocol development through study closeout and regulatory readiness. Serve as the Clinical Operations representative on Program Core Teams, providing strategic operational expertise to support asset-level development planning and decision processes. Partner with the Clinical Science Lead to guide the Clinical Development Sub-Team, fostering cross-functional collaboration, proactive risk management, and timely, informed decisions. Responsible for the successful operational execution of key program milestones (e.g., FPI, enrollment completion, interim analyses, database lock, CSR, regulatory submissions) across all studies within the asset. Study Execution Oversight: Provide oversight of multiple clinical studies across the assigned asset, ensuring consistent execution, quality, timelines, and operational excellence from early through late-stage development. Establish and oversee program-level enrollment, feasibility, country, and site strategies using data-informed forecasting and proactive risk mitigation. Anticipate operational risks and facilitate cross-functional problem-solving to maintain program objectives and timelines. Vendor, CRO & Site Management Develop and oversee CRO and vendor strategies, including partner selection, governance, performance management, and escalation pathways. Oversee and support strategic discussions with CROs and key vendors regarding budgets, work orders, change orders, and Master Service Agreements. Serve as the senior operational escalation point for CRO, vendor, and critical site performance issues. Budget & Financial Oversight Maintain accountability for Clinical Operations budgets across the assigned asset, ensuring accurate forecasting, financial stewardship, and alignment with program objectives. Partner with stakeholders to ensure effective resource planning and operational capacity across all studies within the asset. Support, coach, and develop Clinical Operations team members, fostering a high-performing and inclusive organization while building future capability. Data Quality, Compliance & Regulatory Readiness Ensure all studies maintain a continuous state of inspection readiness in partnership with Quality Assurance and cross-functional teams Oversee operational compliance with SOPs, ICH-GCP, applicable regulatory requirements, and internal quality standards. Foster a culture of quality and proactive issue identification, escalation, and resolution. Process Optimization & Technology Implementation Partner with the Head of Clinical Operations to advance scalable processes, operational best practices, and organizational capabilities. Encourage and support the adoption of new technologies and data-informed approaches (e.g., RBM, advanced data insights, AI/ML-enabled solutions) to enhance trial efficiency and decision quality. Oversee the implementation of enterprise Clinical Operations systems and tools (e.g., eTMF, CTMS, RBM platforms) that enhance operational effectiveness. Cross-functional Collaboration Collaborate closely with Clinical Science, Regulatory Affairs, Data Science, Pharmacovigilance, Biometrics, Medical Monitoring, Clinical Supply, CMC, Tech Ops, Finance, and other cross-functional partners to influence asset strategy and drive successful program execution. Build alignment across functions, effectively influence decision-making, and ensure operational considerations are integrated into asset-level development strategies. Leadership Competencies As a Director, we also expect our leaders to demonstrate the following Leadership Competencies: Communication and Influence Builds communication channels across Maze for sharing information Influences Senior Management decisions through persuasive arguments Respectfully addresses differing opinions leading to support of decision Team