Job Details

Overview

Associate Director, Clinical Operations – PKU at Maze Therapeutics leads PKU clinical development strategy and trial execution. This role partners with cross-functional teams to manage the PKU Phase 2 study, guiding study design, protocol development, and key milestones. The position offers ownership of the clinical program, collaboration with key opinion leaders, and leadership within Clinical Operations.

Responsibilities

• Clinical Trial Execution & Leadership
  • Lead or co-lead the Phase 2 PKU clinical trial, aligning execution with the overall clinical development plan from study design and protocol development to completion of milestones (FPI, enrollment, interim analysis, database lock, CSR).
  • Drive feasibility and site selection to ensure timely enrollment; develop enrollment forecasts.
  • Partner with Clinical Science to engage therapeutic area KOLs and plan clinical advisory committee meetings.
  • Participate on the Clinical Development Sub-Team (CDST) and contribute to clinical development strategy.
• Lead and facilitate engagement with clinical trial vendors, including budget and contract negotiations
• Oversee CROs, vendors, and study sites to ensure alignment with strategic goals
• Budget & Financial Oversight
  • Provide financial oversight across multiple clinical studies, ensuring budget efficiency and alignment with corporate goals
• Data Quality, Compliance & Regulatory Readiness
  • Ensure high-quality clinical trial data and adherence to study protocols, SOPs, ICH GCP; oversee CROs/vendors and monitoring at sites.
  • Partner with Quality Assurance on inspection readiness.
• Process Optimization & Technology Implementation
  • Identify and integrate emerging technologies (AI/ML-driven solutions, analytics) to improve trial planning and execution.
  • Develop best practices and scalable processes with the Clinical Operations Team.
  • Evaluate and implement off-the-shelf systems (eTMF, CTMS, RBM) as appropriate.
• Cross-functional Collaboration
  • Influence program-wide decisions by collaborating with regulatory, data science, CMC, supply chain, and other stakeholders.

Leadership Competencies

As an Associate Director, leadership capabilities include:

• Communication and Influence
  • Communicate rationale behind decisions and foster open communication with internal and external stakeholders.
• Teamwork and Collaboration
  • Facilitate collaboration across teams and manage conflicts constructively.
• Execution and Results
  • Use data-driven judgment, support team problem-solving, and reinforce process compliance and risk mitigation.
• Develop Others and Self
  • Articulate expectations and pursue ongoing development for self and team.

Qualifications

You might be the right fit if you have:

• A Bachelor's degree in a scientific discipline or health-related field with 8–10 years in clinical operations, including leadership of Phases I–III trials, with program-wide and strategic focus.
• Experience in common disease and/or rare disease drug development.
• Familiarity with regulatory guidelines and inspections (FDA, EMA, ICH-GCP).
• Proven capability planning, conducting, and managing clinical trials from start-up to close-out; experience with clinical trial databases (e.g., Medidata RAVE, Veeva) and budgeting.
• Strong strategic thinking, ability to shape development strategy and influence management at study and program levels.
• Startup mindset, ability to work in a fast-paced, evolving, collaborative environment.
• Experience providing program-level leadership and mentoring junior staff; 1–2 years of people management with direct reports is highly desirable.
• Excellent communication skills and ability to influence 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 for renal, cardiovascular, and related metabolic diseases, including obesity. The company uses its Compass platform to map genetic variants to biological pathways and develop targeted therapies. Maze is based in South San Francisco.

Our People and Values

We are a team of professionals committed to transforming patients' lives through science. We foster an environment that encourages vision, initiative, and talent development, while maintaining a patient-centric focus.

Core Values

• Further Together – Team-first approach to overcome challenges.
• Impact Obsessed – Bold actions, calculated risks, and learning from results.
• Stand True – Integrity as a foundation for all decisions.

Compensation & Benefits

The expected annual salary range for employees located in the San Francisco Bay Area is $185,000 - $226,000. This position is eligible for an annual bonus. Maze conducts compensation benchmarking. Starting salary depends on experience, skills, and location. Benefits include medical, dental, vision, mental health offerings, equity, 401(k) with employer match, and generous holiday and PTO policies.

Other Information

Maze supports a hybrid work environment. #LI-Hybrid