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About the Role

Serve as the Study Lead for a complex, global pivotal Phase 3 program in chronic kidney disease (CKD). Responsible for end-to-end study execution, working 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. Guide the Study Execution Team (SET), providing strategic oversight and hands-on execution to support successful trial delivery. Support and develop a high-performing study team, oversee CRO and vendor activities, manage a substantial global study budget, and maintain continuous inspection readiness.

Responsibilities

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.
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.
Maintain accountability for a large global Phase 3 study budget, including forecasting, accruals, variance analysis, scope management, change control, and long-range planning.
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.
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.
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.
Builds communication channels across Maze for sharing information.
Influences Senior Management decisions through persuasive arguments.
Respectfully addresses differing opinions leading to support of decision.
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.
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.
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.

Requirements

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.

Skills

Clinical Operations
Study Lead
Global Study Execution
Protocol Development
Study Start-up
Enrollment
Database Lock
Study Close-out
Submission Support
Inspection Readiness
Risk Management
Vendor Management
CRO Management
Site Management
Budget Management
Forecasting
Accruals
Variance Analysis
Scope Management
Change Control
Long-Range Planning
Quality Assurance
Compliance
ICH-GCP
Process Optimization
Technology Implementation
RBM
Data Insights
AI/ML
Cross-functional Collaboration
Communication
Facilitation
Collaboration
Conflict Resolution
Critical Thinking
Strategic Judgment
Adaptability
Responsiveness

Location

San Francisco Bay Area

Work Type

Hybrid

Experience Level

Director
10-12+ years of clinical operations experience
Study leadership of Phase I-III trials
End-to-end operational lead for a complex large global Phase 3 study
Managing and developing teams

Education Level

Bachelor’s degree in a scientific or health-related field

Salary/Compensations

$232,000 - $283,000
Eligible for an annual performance bonus

Benefits

Competitive medical, dental, and vision insurance
Mental health offerings
Equity incentive plan
401(k) program with employer match
Generous holiday and PTO policy

About the Company

Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing human genetics to develop precision medicines for patients with kidney and metabolic diseases.
Our clinical pipeline is anchored by two small molecule programs: MZE829, an APOL1 inhibitor for patients with APOL1‑mediated kidney disease, and MZE782, which targets genetic drivers of disease in phenylketonuria (PKU) and chronic kidney disease.
We are also advancing a preclinical pipeline through our Compass platform, which links human genetic variants to the biological pathways that drive disease.
Maze is comprised of a team of passionate and creative professionals committed to discovering and delivering transformative medicines to patients suffering from both rare and common genetic diseases.
We are fostering a culture that encourages vision, initiative and the development of talent.
Our supportive work environment inspires creative thinking and freedom of expression, resulting in a stimulating atmosphere where people enjoy coming to work.
While we have a passion for advanced science and pride ourselves on excellence in execution, ultimately, everything we do is about patients.
Further Together – Our path is paved with challenges, but with resilience and a team-first mentality, we’ll achieve our mission.
Impact Obsessed – We embrace the bold, take calculated risks, and learn from our mistakes to improve the lives of others.
Stand True – Our integrity is foundational; it guides us no matter the obstacle.

Equal Opportunity

Maze performs position-based compensation benchmarking to industry market data to ensure we pay competitive wages. Determination of starting salary will depend upon a variety of job-related factors, which may include professional experience, skills, and job location. The expected salary range for this role may be modified in the future.