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 requirements and timely remediation of quality or compliance risks.

Process Optimization & Technology Implementation

Collaborate with the Oversight Director and Head of Clinical Operations to evaluate and implement Clinical Operations best practices, SOP improvements, and scalable processes to support pivotal programs and future organizational growth.

Encourage and support the adoption of new technologies and data-informed approaches, including RBM, advanced data insights, and AI/ML-enabled solutions, to enhance study efficiency and operational effectiveness.

Cross-functional Collaboration

Guide the Study Execution Team (SET), providing operational coordination, strategic direction, and hands-on support to achieve high-quality study deliverables.

Build alignment across Clinical Science, Regulatory Affairs, Biostatistics, Data Management, Safety, Quality, CMC, and Supply Chain functions.

Foster effective communication and partnership across functions by ensuring appropriate stakeholder involvement and utilizing clear communication processes throughout the study lifecycle.

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

Teamwork and Collaboration

Champions partnerships and connections across Maze

Proactively addresses issues that could result in breakdown of team relationships

Spotlights team and individual contributions in public forums

Execution and Results

Addresses gaps and leverages strengths to get best results

Maintains a steadying presence and clarifies priorities during change

Anticipates and removes barriers that put functional/corporate goals at risk

Develop Others and Self

Removes barriers to staff development and empowers them to make their own decisions

Stays current on industry trends and keeps direct-reports prepared and responsive

What We’re Looking For

You might be the right fit for this role if you have:

A Bachelor’s degree in a scientific or health-related field with 10–12+ years of clinical operations experience, including study leadership of Phase I–III trials.

Demonstrated success as the end-to-end operational lead for a complex large global Phase 3 study, including feasibility, startup, enrollment, study conduct, close-out, and inspection readiness.

Experience leading clinical trials in renal, or cardiometabolic diseases is strongly preferred.

Proven experience managing and developing teams, including coaching, mentoring, delegation, and supporting the growth of both managers and early-career professionals.

Expertise in global regulatory requirements (e.g., FDA, EMA, ANVISA, AMA, ICH-GCP), including direct experience supporting audits, inspections, and inspection-readiness activities.

Exceptional critical thinking and strategic judgment, with the ability to synthesize incomplete or evolving information, recommend a clear path forward, and influence decisions at study-team and executive levels.

Strong strategic mindset with the ability to influence executive-level stakeholders.

Experience operating in a hands-on role within a small or high-growth biotech environment, with demonstrated adaptability and responsiveness to changing data and program priorities.

Excellent communication, facilitation, collaboration, and conflict-resolution skills, with the ability to build alignment and productive working relationships across internal and external stakeholders.

Willing to travel up to 30% to support study needs.

About Maze Therapeutics

Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing human genetics to develop precision medicines fo