Associate Director, Clinical Operations, CKD
Mazetx, San Francisco, California, United States, 94199
Associate Director, Clinical Operations, CKD
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 APOL1 Chronic Kidney Disease (CKD) clinical development strategy, partnering with cross-functional teams to drive lead 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 ongoing CKD Phase 2 study. This is an opportunity to take ownership of clinical study, engage with key opinion leaders, and 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 Phase 2 CKD clinical trial, aligning study execution with broader clinical development plan and objectives from study design and protocol development to completion of key study milestones (enrollment completion, data analysis, database lock, and final CSR). Develop study enrollment forecasting and site engagement strategies to drive enrollment. Partner with Clinical Science to engage with therapeutic area KOLs as well as plan clinical advisory committee meetings and patient advocacy engagements. Participate on 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, ensuring alignment with strategic goals. Develop KPIs in collaboration with CRO to help guide oversight and partner with oversight Director to establish governance structure. 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) 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 you 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 others 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 Phase II–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 maintenance, study close-out, 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. The company is advancing a pipeline using its Compass platform to identify and characterize genetic variants in disease and link those variants to the biological pathways that drive disease in specific patient groups. The company’s pipeline is led by two lead programs, MZE829 and MZE782, representing 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 professionals committed to discovering and delivering transformative medicines to patients suffering from rare and common genetic diseases. We foster a culture that encourages vision, initiative and talent development. Our supportive work environment inspires creative thinking and excellence in execution, with a focus on 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 competitive wages. Starting salary will depend on experience, skills, and location, and the range may be modified in the future. Maze offers a robust benefits package including medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) with employer match, and a generous holiday and PTO policy.
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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 APOL1 Chronic Kidney Disease (CKD) clinical development strategy, partnering with cross-functional teams to drive lead 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 ongoing CKD Phase 2 study. This is an opportunity to take ownership of clinical study, engage with key opinion leaders, and 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 Phase 2 CKD clinical trial, aligning study execution with broader clinical development plan and objectives from study design and protocol development to completion of key study milestones (enrollment completion, data analysis, database lock, and final CSR). Develop study enrollment forecasting and site engagement strategies to drive enrollment. Partner with Clinical Science to engage with therapeutic area KOLs as well as plan clinical advisory committee meetings and patient advocacy engagements. Participate on 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, ensuring alignment with strategic goals. Develop KPIs in collaboration with CRO to help guide oversight and partner with oversight Director to establish governance structure. 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) 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 you 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 others 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 Phase II–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 maintenance, study close-out, 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. The company is advancing a pipeline using its Compass platform to identify and characterize genetic variants in disease and link those variants to the biological pathways that drive disease in specific patient groups. The company’s pipeline is led by two lead programs, MZE829 and MZE782, representing 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 professionals committed to discovering and delivering transformative medicines to patients suffering from rare and common genetic diseases. We foster a culture that encourages vision, initiative and talent development. Our supportive work environment inspires creative thinking and excellence in execution, with a focus on 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 competitive wages. Starting salary will depend on experience, skills, and location, and the range may be modified in the future. Maze offers a robust benefits package including medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) with employer match, and a generous holiday and PTO policy.
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