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About the Role
As an Oversight Director, Clinical Operations at Maze Therapeutics, you will provide strategic and operational direction across the full development lifecycle for an asset spanning CKD and PKU portfolios. You will ensure the successful execution of multiple studies, delivering high-quality clinical trials on time and within budget. This role involves guiding the Clinical Development Sub-Team, overseeing CRO and vendor strategies, managing study execution, operational risk, resource planning, financial oversight, and ensuring inspection readiness.
Responsibilities
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Build communication channels across Maze for sharing information.
- Influence Senior Management decisions through persuasive arguments.
- Respectfully address differing opinions leading to support of decision.
- Champion partnerships and connections across Maze.
- Proactively address issues that could result in breakdown of team relationships.
- Spotlight team and individual contributions in public forums.
- Address gaps and leverage strengths to get best results.
- Maintain a steadying presence and clarify priorities during change.
- Anticipate and remove barriers that put functional/corporate goals at risk.
- Remove barriers to staff development and empower them to make their own decisions.
- Stay current on industry trends and keep direct-reports prepared and responsive.
Requirements
- Bachelor’s degree in a scientific or health-related field.
- 12–15+ years of progressive clinical operations experience.
- Leadership of global Phase I–III clinical trials.
- Oversight of one or more development assets.
- Demonstrated success providing operational direction across multiple studies within a development program, driving strategy, execution, and delivery of key program milestones.
- Proven experience guiding and developing high-performing Clinical Operations teams, including direct management, coaching, and mentoring of Study Leads and other Clinical Operations professionals.
- Deep expertise in global clinical trial operations, including FDA, EMA, ICH-GCP, and other applicable regulatory requirements, with a strong track record of maintaining inspection readiness.
- Extensive experience developing and overseeing CRO and vendor partnerships, including governance, performance management, contract negotiations, and budget accountability.
- Strong financial acumen with experience managing large, complex clinical trial budgets, forecasting, and resource planning.
- Demonstrated ability to identify operational risks, facilitate cross-functional problem-solving, and contribute to strategic planning in a fast-paced development environment.
- Experience building scalable processes, implementing operational best practices, and contributing to organizational growth within a biotech or similarly dynamic environment.
- Excellent communication, collaboration, and relationship-building skills, with the ability to build trust, foster alignment, and work effectively across all levels of the organization, including senior leadership and external partners.
- Willingness to travel up to 30% to support study needs.
Skills
- Clinical Operations
- Clinical Trial Management
- Global Clinical Trial Operations
- FDA
- EMA
- ICH-GCP
- CRO Management
- Vendor Management
- Budget Management
- Financial Forecasting
- Resource Planning
- Risk Management
- Process Optimization
- Technology Implementation
- Communication
- Collaboration
- Relationship Building
- Leadership
- Coaching
- Mentoring
Location
- San Francisco Bay Area
Work Type
- Hybrid
Experience Level
- Director
- 12-15+ years
Education Level
- Bachelor's degree in a scientific or health-related field
Salary/Compensations
- $232,000 - $283,000
- 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.
- Our Core Values: Further Together, Impact Obsessed, Stand True.