Director Operational Risk Jobs in San Jose, CA (NOW HIRING)

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.

• 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
• 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

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

• A Bachelor's degree in a scientific or health-related field with 12–15+ years of progressive clinical operations experience, including leadership of global Phase I–III clinical trials and 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.

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 – 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.

The expected annual salary range for employees located in the San Francisco Bay Area is $232,000 - $283,000. Additionally, this position is eligible for an annual performance bonus.

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.

Maze offers a robust benefits package to our eligible employees including competitive medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) program with employer match and a generous holiday and PTO policy.

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