Associate Director, Clinical Operations - PKU at Maze Therapeutics

South San Francisco, California, United States -

Full Time

Start Date

Immediate

Expiry Date

19 Dec, 25

Salary

226000.0

Posted On

20 Sep, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Operations, Clinical Trial Execution, Budget Management, Vendor Management, Regulatory Compliance, Data Quality, Strategic Thinking, Team Leadership, Communication, Collaboration, Process Optimization, Technology Implementation, Clinical Development, KOL Engagement, Study Management, Risk Mitigation

Industry

Biotechnology Research

Description

The Position At Maze Therapeutics, we believe that precision medicine has the power to transform the lives of patients with both common and rare diseases. As an Associate Director of Clinical Operations, you will be at the heart of our Phenylketonuria (PKU) clinical development strategy, partnering with cross-functional teams to drive clinical trial execution. You’ll work closely with the Clinical Development Sub-Team, providing both strategic and hands-on leadership to ensure the success of our PKU Phase 2 study. This is an opportunity to take ownership of clinical program, engage with key opinion leaders, and meaningfully contribute to our Clinical Operations department. If you enjoy rolling up your sleeves, collaborating across teams, and bringing innovative medicines to patients, this role could be the perfect fit for you. The Impact You’ll Have Clinical Trial Execution & Leadership Lead or co-lead Phase 2 PKU clinical trial, aligning study execution with broader clinical development plan and objectives from study design and protocol development to completion of key study milestones (FPI, enrollment completion, interim analysis, database lock, and final CSR). Drive study feasibility efforts to inform site selection strategy to ensure timely study enrollment and completion; develop study enrollment forecasts. Partner with Clinical Science to engage with therapeutic area KOLs as well as plan clinical advisory committee meetings. Participate on Clinical Development Sub-Team (CDST) and contribute to clinical development strategy. Vendor, CRO & Site Management Lead and facilitate engagement with clinical trial vendors, including budget and contract negotiations Oversee CROs, vendors, and study sites, ensuring 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 guidelines through overall study management, diligent oversight of CROs/vendors and monitoring activities at investigative sites. Partner with Quality Assurance on inspection readiness. Process Optimization & Technology Implementation Take a leadership role in identifying and integrating emerging technologies (AI/ML-driven solutions, advanced analytics) to improve trial planning and execution. Partner with Clinical Operations Team in the development of best practices and scalable processes. Partner with Clinical Operations Team and other internal stakeholders to evaluate off the shelf systems and tools (e.g. eTMF, CTMS, RBM, etc.) to license and implement at Maze. Cross-functional Collaboration Work at a higher strategic level, collaborating with cross-functional stakeholders to influence program-wide decisions, including clinical development, regulatory, data science, CMC and supply chain. As an Associate Director, we also expect our leaders to demonstrate the following Leadership Competencies: Communication and Influence Communicates the reasoning behind decisions to appropriate stakeholders. Promotes open communication with internal and external stakeholders. Fosters healthy and respectful debate. Teamwork and Collaboration Creates opportunities for team members to connect with others outside of team. Manages conflict effectively between teams. Openly values thoughts, opinions, and contributions of employees. Execution and Results Exercises astute judgment to make decisions with only the necessary amount of data. Supports team members in creating their own resolutions to challenges and problems. Works with other to reinforce process compliance, what good looks like, and risk mitigation. Develop Others and Self Articulates what good looks like throughout Maze. Pursues development activities for continuous improvement of self and team. What We’re Looking For You might be the right fit for this role if you have: A Bachelor’s degree in a scientific discipline or health related field with 8–10 years of clinical operations experience, including leadership of Phases I–III trials, with a broader 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) A proven track record planning, conducting, and managing clinical trials including study start-up to study close-out, clinical trial databases (e.g., Medidata RAVE, Veeva), and knowledge of clinical trial budgeting. Strong knowledge of FDA, EMA, ICH-GCP guidelines and inspection experience preferred), proficiency with clinical trial databases (e.g., Medidata RAVE, Veeva), and knowledge of clinical trial budgeting. Direct experience analyzing, negotiating, and managing clinical trial budgets and vendors and leveraging technology to drive clinical trial efficiency. Strong strategic thinking, ability to shape clinical development strategy, and influence management at both study and program levels. A startup mindset, willingness to roll up sleeves, and ability to work in a fast-paced, evolving, and collaborative team environment. Experience providing program-level leadership, mentoring junior staff, and driving strategic decision-making. 1 – 2 years of people management experience with at least 2-3 direct reports highly desirable. Excellent communication skills and the ability to influence internal and external stakeholders. Are willing to travel up to 30% to support study needs. About Maze Therapeutics Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal, cardiovascular and related metabolic diseases, including obesity. The company is advancing a pipeline using its Compass platform, which allows it to identify and characterize genetic variants in disease and then link those variants to the biological pathways that drive disease in specific patient groups through a process it refers to as variant functionalization. The company’s pipeline is led by two wholly owned lead programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach for chronic kidney disease. Maze is based in South San Francisco. Our People 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 $185,000 - $226,000 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. #LI-Hybrid

Responsibilities

Lead or co-lead Phase 2 PKU clinical trial, ensuring alignment with the broader clinical development plan. Oversee vendor and CRO management, ensuring budget efficiency and high-quality data compliance.