The Position

At Maze Therapeutics, we believe precision medicine has the power to transform the lives of patients with both common and rare diseases. As a Machine Learning Application Engineer II, you will play a hands‑on role in delivering high‑impact, production‑grade solutions that advance our drug discovery programs. You will design, build, and scale data and machine learning infrastructure across early research, lead optimization, and development stages of the drug discovery pipeline. In this role, you will enable data‑driven science while upholding strong engineering standards and FAIR data principles. 

This position reports to a Senior Data Engineer. 

The Impact You’ll Have

• Support management of biobank scale datasets in Polaris, Maze’s internal platform supporting Compass, by building scalable data ingestion, cleaning, processing, and validation pipelines. 
• Work with scientific compute teams to design and deploy machine learning models to support workflows in research and small molecule drug discovery (compound property prediction, assay data prediction, data analysis). 
• Lead the evaluation and integration of Large Language Models (LLMs) to automate data ingestion workflows, enhance intelligent querying, and support user-facing variant association and scientific visualization platforms. 
• Design and operate scalable ML and data platforms leveraging Terraform (IaC) and Git-based CI/CD pipelines, incorporating workflow orchestration, automated model lifecycle management, and production-grade monitoring and reliability. 
• Collaborate with development organization to evaluate and deploy ML tools that support workflows across Regulatory, Clinical Operations, and Medical Affairs. 
• Collaborate cross-functionally translate scientific requirements into production-grade systems. 

What We’re Looking For

• Master’s degree in Computer Science, Machine Learning, Bioinformatics, Data Engineering, or related fields. 
• 3+ years of industry experience building production-grade data and ML pipelines, preferably in life sciences supporting drug discovery. 
• Hands-on experience deploying AI/ML models in drug discovery applications (e.g., computational biology/chemistry workflows). 
• Experience with FAIR data principles and strong programming skills in Python and SQL (R is a plus). 
• Proven experience in deploying and maintaining ML systems, including CI/CD, workflow orchestration, and monitoring. 
• Experience with workflow orchestration tools (e.g., Airflow, Prefect). 
• Experience with containerization and cloud infrastructure (Docker, Kubernetes, AWS or similar). 

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 $154,000 - $188,000. 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

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 a Senior Clinical Trial Specialist (Sr. CTS) at Maze Therapeutics, you’ll play a key role in supporting our Clinical Operations team as we deliver an exciting clinical trial in the rare disease, Phenylketonuria (PKU). You’ll collaborate closely with internal teams, CROs, and vendors to ensure the smooth execution of our clinical studies. This role is best suited for someone who is organized, detail-oriented, and proactive. The ideal candidate enjoys problem-solving, thrives in a fast-paced environment, and is eager to take ownership of critical trial activities such as vendor and site management.

The Impact You’ll Have

You’ll be a critical part of our clinical team, ensuring our trials are executed with precision, efficiency, and the highest standards of quality. Your contributions will include:

• Driving Study Execution: Partner with the Clinical Operations team to oversee and monitor the conduct of our global Phase 2 PKU study, monitoring and tracking progress, identifying trends or issues, and collaborating with Study Leads to implement corrective actions when necessary.
• Site, Vendor Management & Oversight:
  • Lead site management oversight (e.g., reviewing reports, conducting QC checks, escalating trends to Global Site Manager) to ensure CRO activities align with the study plans and protocol. Facilitate any deviation discussions for quick resolution. Identify site trends, opportunities for training, and creating tracking tools to ensure sponsor oversight.
  • Manage one or more clinical trial vendors from study-start to close-out, including day-to-day management, budget oversight, and escalating to Study Lead as, appropriate.
  • Identify gaps quickly, hold vendors/CRAs accountable, provide solutions, and escalate risks in a timely manner.
• Ensuring compliance & Best Practices: Ensure that all clinical trial activities adhere to ICH/GCP Guidelines, study plans and protocols, and Maze SOPs.
• Supporting Key Study Materials: Assist in the design, development, and review of study documents, including protocols, informed consent forms (ICFs), amendments, and content creation for study materials.
• Collaboration & Leadership: Attend and contribute to vendor meetings, lead resolution of study-related issues, and foster a culture of continuous process improvement with CROs and other external partners.
• Tracking & Documentation: Oversee Trial Master File (TMF) activities, ensuring proper documentation, metric tracking and reconciliation efforts as needed.
• Sample & Data Management: Work with study team to coordinate and track sample shipments, sample analysis, and data reconciliation efforts.
• Cross-Functional Collaboration: Serve as a point of contact for study-related inquiries and provide high-level administration, coordination, and organizational support to the Clinical Operations team.
• Process & SOP Development: Contribute to creation and refinement of Clinical Operations standard operating procedures (SOPs) and process documents to optimize study execution.

What We’re Looking For

We’re looking for someone who’s not just checking the boxes but is truly passionate about bringing high quality clinical trials to life. You might be a great fit if you have:

• A strong clinical operations background: Bachelor’s degree with 2-3+ years of experience in Clinical Operations within a biotech or pharmaceutical environment.
• A systematic and problem-solving mindset: You enjoy solving complex challenges and thinking critically to improve processes.
• Exceptional organizational skills: You can manage multiple priorities, staying detail-oriented, and keep trials on track.
• A proactive and collaborative approach: You’re a strong team player who takes initiative and builds meaningful relationships with internal and external partners.
• Hands-on experience with trial systems: Familiarity with clinical trial databases such as Medidata Rave, Veeva, or similar platforms.
• Flexibility and adaptability: You thrive in a fast-paced, evolving environment and willing to roll-up your sleeves to perform a broad range of clinical trial related tasks as needed.
• Willingness to travel: Up to 10-15% travel, with the possibility of more based on project needs as necessary.
• Strong computer proficiency (Microsoft Office Suite- Word, Excel, Outlook).

This role follows a hybrid schedule, with an expectation to be onsite at our South San Francisco headquarters at least two days per week.

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 $125,000 to $152,000. 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

The Opportunity: 

Join Maze Therapeutics as an Associate Director, Regulatory Affairs, where you will play a critical role in advancing our clinical-stage programs by providing regulatory expertise and executional leadership. As a key member of the development team, you will collaborate with cross-functional teams to manage and support global regulatory activities. Reporting to the Senior Director of Regulatory Affairs, you will be responsible for preparing regulatory submissions, facilitating interactions with Health Authorities, and ensuring successful execution of regulatory plans.

The Impact You’ll Have: 

• Represent Regulatory Affairs for assigned programs, providing regulatory leadership and guidance, identifying regulatory risks and developing mitigation strategies, and leading the execution of regulatory plans.
• Contribute to the development and implementation of regulatory strategies for assigned programs in alignment with corporate objectives and regulatory requirements.
• Conduct regulatory research to provide recommendations for various regulatory scenarios, proactively identify risks, and inform regulatory strategies.
• Plan and manage regulatory activities across clinical, nonclinical, and CMC functions to enable timely and efficient program advancement.
• Lead the preparation and maintenance of regulatory submissions, including INDs/CTAs, periodic reports, expedited program requests, and Health Authority responses.
• Provide regulatory input on key development documents, including clinical protocols, statistical analysis plans, and clinical/nonclinical study reports, to ensure alignment with regulatory expectations.
• Support the planning, preparation, and execution of Health Authority interactions by contributing to meeting strategy, drafting briefing documents, and coordinating responses.
• Collaborate with cross-functional teams and external partners to ensure regulatory deliverables are high-quality and aligned with development timelines.
• Champion the development and continuous improvement of Regulatory Affairs processes to enhance compliance and operational efficiency.

What We’re Looking For: 

• Bachelor's degree required; advanced degree in life sciences
• 4-7+ years or equivalent relevant experience in regulatory affairs in the biopharmaceutical industry
• Strong understanding of ICH guidelines and US/EU regulatory requirements, with experience supporting global regulatory filings
• Hands-on experience preparing and managing IND/CTAs and related submissions required; NDA/MAA experience a plus
• Ability to manage multiple projects in a fast-paced environment, proactively identifying challenges and collaborating cross-functionally to develop solutions
• Strong organizational and communication skills, with the ability to clearly convey regulatory concepts to cross-functional teams

 This role follows a hybrid schedule, with an expectation to be onsite at our South San Francisco headquarters at least three days per week.  

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 $199,000-244,000. 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

The Opportunity

Step into a pivotal role where science meets strategy. At Maze, we’re on a mission to uncover genetic insights and transform them into precision medicines that change lives. Our team is driven by curiosity, collaboration, and a commitment to improving treatment for people with severe diseases. We thrive on diverse perspectives and bold ideas, and we’re looking for someone who shares that spirit.

As our Head of Quality, you’ll shape and lead the Quality function at Maze, guiding strategy, systems, and compliance across our development programs. You’ll be instrumental in evolving our GxP processes and ensuring we’re inspection ready as we move into Phase 2 and beyond, with a focus on robust vendor oversight and building scalable systems to support late-stage and future commercial success.

Reporting to the Vice President of Regulatory and Quality Science, you’ll manage and develop two direct reports and foster a culture of collaboration, accountability, and continuous learning that extends across the organization.

The Impact You’ll Have

• Be accountable for and evolve Maze’s GxP Quality strategy, providing leadership across internal operations and external partners, including CROs, CMOs, CTLs, and vendors supporting GxP activities
• Drive cross-functional integration of Quality across programs, ensuring timely engagement in key decisions
• Develop and implement risk-based Quality approaches for investigational materials, ensuring phase-appropriate systems from early development through commercialization, and proactively identify and mitigate quality risks
• Lead the development and continuous improvement of Quality Systems and SOPs supporting GxP activities
• Provide Quality oversight and input for regulatory submissions and correspondence, including INDs, IMPDs, CTAs, and interactions with FDA and global health authorities
• Provide Quality leadership for clinical programs, including oversight of CROs and clinical trial activities, ensuring GCP compliance and readiness for clinical inspections
• Partner strategically with CMC and lead GMP vendor oversight to ensure manufacturing, testing, packaging, labeling, and distribution activities comply with cGMP, FDA, ICH, EMA, and industry standards.
• Lead QA investigations, including product-impacting issues, and provide oversight and approval of CAPAs from deviations, complaints, recalls, audits, and inspections, ensuring timely and effective resolution and closure of findings
• Drive Maze’s inspection readiness and serve as the lead Quality representative during health authority inspections
• Represent QA on cross-functional teams and company initiatives, providing Quality leadership and guidance in decision-making
• Stay current on evolving global regulations and industry best practices related to GxP and compliance, and apply these insights to strengthen Maze’s Quality frameworks and systems
• Develop and deliver GxP training across Maze, identifying opportunities for continuous improvement and embedding industry best practices into daily operations
• Oversee Document Control systems, ensuring compliance, consistency, and effective lifecycle management of Quality records

As a Senior Director, we also you to demonstrate the following Leadership Competencies:

• Communication and Influence
  • Role models clear communication and open two-way conversations.
  • Reinforces an environment where people feel heard and their opinions are valued.
  • Inspires followership despite differing initial opinions.
• Teamwork and Collaboration
  • Champions collaborations and connections across Maze.
  • Establishes team norms and expectations.
  • Seeks opportunities to spotlight team and individual contributions in public forums.
• Execution and Results
  • Develops recommendations to seize on opportunities and mitigate obstacles that could impact long-term success.
  • Coaches others on resource management and work distribution/delegation.
  • Aligns work to Maze’s strategy, mission, and vision.
• Develop Others and Self
  • Develops staff capabilities to handle delegation of responsibilities.
  • Encourages staff to develop and execute personal stretch goals.
  • Identifies and recommends ways to increase inclusive leadership.

What We’re Looking For

• Bachelor’s degree in a scientific discipline with 12+ years of progressive experience in biotech or pharma GxP quality assurance and compliance
• Deep knowledge of global GxP regulations, including U.S. CFR, EMA, ICH, and other relevant standards
• Proven experience in building and refining QA related systems that support clinical and commercial development
• Strong understanding of GMP Quality across raw materials, drug substance, drug product, labeling, packaging, and distribution, including testing, stability, and retention
• Strong understanding of GCP Quality, including CRO oversight, clinical trial conduct, and inspection readiness
• Experience enabling release of investigational and commercial materials in compliance with regulatory requirements
• Skilled in GxP training and implementation, with a focus on practical adoption
• Track record of leading and supporting regulatory inspections, including FDA, EMA, and global agencies
• Experience drafting audit responses and implementing CAPAs
• Proficiency in root cause analysis and CAPA management
• Familiarity with eQMS and eTMF systems
• Experience managing and developing direct reports, with a focus on mentorship and professional growth
• Collaborative mindset, with experience working across internal teams and external partners
• Strong strategic and organizational skills, with the ability to prioritize multiple projects
• Excellent leadership and communication skills (written and oral)
• High ethical standards with a positive, proactive, and solution-oriented approach
• Willingness to travel domestically and internationally for inspections, vendor oversight, and industry events

This role follows a hybrid schedule, with an expectation to be onsite at our South San Francisco headquarters at least three days per week

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 $257,000 - $314,000. 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

The Opportunity

Join us at Maze Therapeutics as our Director of Data Management, where you will play a key role in shaping the data strategy that supports our clinical development programs.  You’ll partner closely with Biostatistics, Statistical Programming, Clinical Operations, and Regulatory Affairs, and oversee external vendors to deliver high-quality, reliable clinical data across our studies.

Reporting to the Vice President of Biometrics, you’ll provide strategic direction and hands-on leadership for clinical data management activities spanning multiple clinical trials. Your work will ensure timely, compliant, and analysis-ready data that supports regulatory submissions and key program decisions.  

The Impact You’ll Have

• Lead data management activities across multiple clinical studies and development phases.
• Shape and implement data management strategies, standards, and best practices.
• Mentor and support data management team members, fostering growth and knowledge sharing.
• Serve as a subject matter expert for data management processes, systems, and regulatory expectations.
• Oversee critical study deliverables including DMPs, CRFs/eCRFs, edit checks, and database locks.
• Guide accurate, consistent, and timely clinical data collection, cleaning, and reconciliation.
• Review and approve key study documentation and ensure readiness for analysis and reporting.
• Drive database lock planning and partner closely with Biostatistics and Medical Writing to support analyses and study reports.
• Manage CROs and external vendors, ensuring clarity around timelines, quality expectations, and contractual commitments.
• Support the evaluation, implementation, and optimization of EDC and data management technologies.
• Collaborate closely with Clinical Operations, Biostatistics, and other partners across the organization.
• Provide data management insights for protocols, study design, and operational planning, while proactively communicating risks and mitigation strategies to senior leadership.

As a Director, we also expect you 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 decisions.
• 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
  • Remove barriers to staff development and empowers them to make their own decisions.
  • Stays current on industry trends and keeps direct-reports prepared and responsive.

What We’re Looking For

• Bachelor’s or advanced degree in Life Sciences, Computer Science, or related field 
• 8+ years of clinical data management experience in biotech, pharmaceutical, or CRO environments
• 3+ years of people and/or project leadership experience
• Hands-on experience with EDC systems (e.g., Medidata Rave, Oracle InForm)
• Strong understanding of clinical trial operations, data flows, and regulatory expectations
• Collaborative, mentorship-oriented leadership stylewith the ability to influence across teams

This role follows a hybrid schedule, with an expectation to be onsite at our South San Francisco headquarters at least three days per week.   

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 $232,000 - $284,000. 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

The Position

As the Director, Biostatistics, you will play an important role in shaping and supporting the clinical development of Maze’s therapeutic programs. You will partner closely with Clinical Science, Regulatory Affairs, Clinical Pharmacology, Development Science, and Translational Science to ensure our clinical studies are robust, data-driven, and impactful.

In this role, you’ll oversee biostatistical strategy and execution, from study design through regulatory submissions, balancing hands-on expertise with strategic leadership. You will also represent Biostatistics on clinical study teams, guide interpretation of complex data, and oversee CRO partners to ensure high-quality statistical deliverables.

The position will report to the Vice President, Biometrics.

The Impact You’ll Have

• Serve as the biostatistics lead for clinical studies, providing expert input on study design, endpoints, and statistical strategy
• Oversee and contribute to completion of all technical and operational statistical activities for a group of clinical trials. Ensure development and review of statistical analysis plans (SAPs), including complex and innovative methodologies
• Collaborate with cross-functional partners in protocol development, study design discussions, and data interpretation
• Partner with Statistical Programming to generate and validate analyses for internal use, publications, and regulatory submissions
• Oversee CRO execution of statistical tasks: managing timelines, quality, and analytical approaches
• Represent biostatistics in regulatory interactions (FDA, EMA, PMDA, etc.), contributing to briefing documents, meeting preparation, and responses to agency questions
• Contribute to clinical study reports (CSRs), integrated summaries (ISS/ISE), and regulatory submissions (NDA/BLA/MAA)
• Apply advanced statistical techniques to explore, analyze, and interpret clinical, safety, biomarker, and exploratory data
• Advise internal and external partners on statistical approaches, data reliability, model selection, and interpretation of results
• Lead the gathering, organization and analysis of different data sources to enable delivery of special projects and / or the statistical analysis plan and clinical study endpoints for assigned products
• Review and analyze safety reporting, biomarker analyses and other aspects of clinical trial monitoring
• Develop enhancements to statistical software, as appropriate, by programming new techniques; maintain knowledge of current and emerging trends in statistical analysis methodologies and tools
• Provide biostatistical input into clinical development documentation, scientific publications and presentations, and regulatory documentation
• Adhere to regulatory requirements of study conduct, statistical analysis principles, industry standards, and Maze SOPs
• Support due diligence, licensing, and partnering activities as needed

As a Director, we also expect you 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 decisions.
• 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
  • Remove barriers to staff development and empowers them to make their own decisions.
  • Stays current on industry trends and keeps direct-reports prepared and responsive.

What We’re Looking For

• An advanced degree in Biostatistics, Statistics, or a related field.
  • Master’s degree with 10+ years of experience, or Ph.D. with 8+ years of experience
• Comfortable being hands-on with analysis, simulations, and document review
• Direct experience designing early-stage trials (Phase I/II) and late-stage trials in resource-constrained settings
• Confident decision-maker who can influence at the executive level
• Collaborative, mentorship-oriented leadership style

This role follows a hybrid schedule, with an expectation to be onsite at our South San Francisco headquarters at least three days per week

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 $228,000 – $280,000. 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

The Opportunity

At Maze Therapeutics, we believe that precision medicine has the power to transform the lives of patients with both common and rare diseases. As a Clinical Trial Manager (CTM) at Maze Therapeutics, you’ll play a hands-on role in co-leading and driving the execution of our Chronic Kidney Disease (CKD) clinical trials. You’ll have the opportunity to contribute to mid to late-stage clinical studies, work cross-functionally with internal teams and external partners, and ensure trials run efficiently and with the highest quality standards. 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

• Steer the execution of one or more of our Phase 2 CKD clinical trials; from protocol development to achievement of corporate and study milestones such as first patient in, interim analysis, database lock, and study report completion. 
• Manage external vendors including CROs, additional key vendors, and global investigative sites. 
• Ensure adherence to study protocols, SOPs, ICH GCP guidelines by overseeing monitoring activities at investigative sites. 
• Coordinate the development of study materials such as CRFs, ICFs, patient diaries. 
• Act as the voice of Clinical Operations on cross-functional teams, including the Study Execution Team (SET). 
• Partner with Clinical Operations and Clinical Science Team to engage with therapeutic area KOLs and Investigators. 

What We’re Looking For

• A degree in a scientific discipline or health related field.
• Minimum of 4 years clinical research experience, including 2 years as a Clinical Trial Manager at a biopharmaceutical company or CRO.
• Experience with planning and executing Phase I-II trials is preferred. 
• Demonstrated proficiency in implementing, monitoring, and management of clinical trials, from start-up to close-out. 
• General knowledge of FDA regulatory requirements and ICH GCP guidelines. 
• Strong organizational skills, ability to prioritize and multi-task. 
• Excellent verbal and written communication skills. 
• Demonstrated problem-solving and negotiation abilities. 
• Ability to work as part of a team and build strong working relationships with internal and external partners.   
• Capacity to roll-up sleeves to perform a broad range of clinical trial related tasks as needed. 
• Willingness to travel as necessary, consistent with project needs. 
• Excellent computer proficiency (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook). 
• Experience with clinical trial databases (e.g., Medidata Rave, Veeva, etc.). 

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 $143,000 - $175,000. 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

The Opportunity

As Senior Director of Pharmaceutical Development, you lead all small molecule drug product activities and serve as a technical expert overseeing processes at CDMOs. You guide formulation and process development, manage scaleups, and proactively identify risks, gaps, and solutions across CMC. You’ll dig into process and analytical data to resolve key challenges and advise on the best path forward. 

You bring strong cGMP expertise, support regulatory submissions, and collaborate across research, development, and technical operations. You coach teams for excellence, fuel intellectual curiosity, and champion inclusive, impactful leadership. 

This position reports to Vice President, Technical Operations. 

The Impact You’ll Have

• Lead small molecule drug product formulation, process development, and manufacturing activities with external CDMOs. 
• Ensure drug products meet quality, cost, time, safety, and operational goals. 
• Evaluate CDMO capabilities and recommend approaches for development and manufacturing. 
• Drive formulation, process development, scaleup, and tech transfer from initiation through regulatory approval. 
• Shape and optimize CMC strategy, project plans, and execution. 
• Monitor daily CMC activities, resolve challenges, and ensure cGMP compliance. 
• Ensure CDMO processes meet needs across formulation development, tox studies, clinical trials, and commercial launch. 
• Assess and implement new methods, tools, and technologies that elevate program success. 
• Analyze scientific data, review batch documentation, and contribute to regulatory filings (IND/IMPD/CTA/NDA). 
• Review and approve master and executed batch records; lead process improvements and drive solutions. 
• Lead technical investigations, identify root causes, and implement corrective actions for deviations. 
• Collaborate effectively across teams with integrity, impact, and a values-driven mindset. 
• Represent Tech Ops and CMC in cross-functional settings. 

As a Senior Director, we also expect you to demonstrate the following Leadership Competencies:

Leadership Competencies

• Communication and Influence
  • Role models clear communication and open two-way conversations. 
  • Reinforces an environment where people feel heard and their opinions are valued. 
  • Inspires followership despite differing initial opinions. 

• Teamwork and Collaboration
  • Champions collaborations and connections across Maze. 
  • Establishes team norms and expectations. 
  • Seeks opportunities to spotlight team and individual contributions in public forums. 

• Execution and Results
  • Develops recommendations to seize on opportunities and mitigate obstacles that could impact long-term success. 
  • Coaches others on resource management and work distribution/delegation. 
  • Aligns work to Maze’s strategy, mission, and vision. 

• Develop Others and Self
  • Develops staff capabilities to handle delegation of responsibilities. 
  • Encourages staff to develop and execute personal stretch goals. 
  • Identifies and recommends ways to increase inclusive leadership. 

What We’re Looking For

• PhD/MS/BS in Pharmacy, Pharmaceutics, Chemical Engineering, or related field. 
• 15+ years of experience in Drug Product CMC development and manufacturing. 
• Deep expertise in small molecule Drug Product CMC from preclinical through commercial stages. 
• Experience leading Drug Product functions in biotech/pharma across multiple programs. 
• Strong knowledge of GMP and ICH guidelines; experience authoring regulatory submissions is a plus. 
• Direct manufacturing experience preferred. 
• Proven success in tech transfer and scaleup. 
• Ability to strategically and pragmatically partner with CDMOs to optimize quality and operations. 
• Handson formulation development experience and the ability to share knowledge with external partners. 
• Strong attention to detail and a talent for building robust Drug Product processes. 
• Comfort navigating fast-paced, evolving startup environments. 
• A self-starter mindset with strong leadership, communication, and decision-making skills. 
• Willingness to travel as needed to support CMC goals with external partners. 

This role follows a hybrid schedule, with an expectation to be onsite at our South San Francisco headquarters at least three days per week 

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 $257,000 - $315,000. 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

The Position

The Clinical Development team is seeking a Senior Director, Safety Science to establish, lead, and scale safety science and pharmacovigilance (PV) at Maze. This role will serve as Maze’s first internal Safety Science leader, with responsibility to build the safety function from the ground up while providing enterprise-level leadership across the clinical portfolio. 

In this highly visible and hands-on leadership role, you will define and own the safety strategy across our clinical programs, spanning both common and rare diseases in nephrology and cardiometabolic indications.   

You will have end-to-end responsibility for safety surveillance, adverse event reporting, risk management, and PV governance, while partnering closely with Clinical Development, Regulatory, Biostatistics, and Clinical Operations. As Maze advances programs from early to late-stage development, you will play a critical role in shaping safety strategy, influencing decision-making, and ensuring patient safety remains central to our work. 

This position reports to the Head of Clinical Development. 

The Impact You’ll Have

In this role, you will combine deep safety scientific expertise with senior-level leadership and a willingness to operate in both strategic and executional modes. 

• Safety Strategy & Oversight 
  • Lead and build Maze’s safety science and PV function, scaling the strategy, activities, and team to support the development lifecycle from early clinical development through late-stage studies and regulatory submissions 
  • Serve as the primary internal owner of safety science and PV activities, directly overseeing day-to-day safety operations while establishing future-state processes and capabilities 
  • Lead safety surveillance and signal identification activities, proactively identifying risks and developing mitigation strategies 
  • Provide strategic and operational oversight for case processing, adverse event reporting, and regulatory compliance 
  • Oversee the preparation, review, and submission of aggregate safety reports and safety sections of clinical and regulatory documents 
  • Author and maintain safety-related content for clinical and regulatory documents, while establishing scalable content standards and governance for future team expansion. 
  • Guide benefit-risk assessments and safety-related recommendations that inform program progression and development decisions 
• Leadership & Collaboration 
  • Establish Maze’s Safety Science and PV function, defining vision, operating model and fostering a culture of accountability, development, and scientific rigor 
  • Partner cross-functionally to develop and execute Safety Management plans aligned with program and corporate objectives 
  • Serve as a subject matter expert in internal governance forums and external discussions with KOLs, advisors, and health authorities. 
  • Influence senior stakeholders across functions to align on safety strategy, risk tolerance, and development trade-offs 
• Operational Excellence 
  • Oversee and directly engage in operational PV activities as needed, including close collaboration with external consultants supporting case processing and compliance 
  • Design and evolve a scalable PV operating model that transitions from external support to internal ownership over time 
  • Provide strategic direction for outsourced PV activities, including CROs, consultants, and vendors 
  • Anticipate operational or compliance risks and proactively implement solutions that protect patients and enable program success  

As a Senior Director, we also expect you to demonstrate the following Leadership Competencies: 

• Communication and Influence
  • Role models clear communication and open two-way conversations. 
  • Reinforces an environment where people feel heard and their opinions are valued. 
  • Inspires followership despite differing initial opinions. 
• Teamwork and Collaboration
  • Champions collaborations and connections across Maze. 
  • Establishes team norms and expectations. 
  • Seeks opportunities to spotlight team and individual contributions in public forums. 
• Execution and Results
  • Develops recommendations to seize on opportunities and mitigate obstacles that could impact long-term success. 
  • Coaches others on resource management and work distribution/delegation. 
  • Aligns work to Maze’s strategy, mission, and vision. 
• Develop Others and Self
  • Develops staff capabilities to handle delegation of responsibilities. 
  • Encourages staff to develop and execute personal stretch goals. 
  • Identifies and recommends ways to increase inclusive leadership. 

What We’re Looking For

• Advanced degree in health sciences (MD/DO, PharmD, PhD) with 7+ years of experience in pharmacovigilance and drug safety, including hands-on operational leadership and strategic oversight of late-stage clinical programs and/or regulatory submissions 
• Demonstrated experience building or standing up safety science or PV capabilities in a resource-constrained or high-growth environment 
• Deep and current knowledge of global pharmacovigilance regulations, safety requirements, and evolving regulatory expectations. 
• Experience with medical review of individual case reports (ICSRs), signal detection, cumulative safety assessments, and risk management planning 
• Proven ability to move fluidly between strategic leadership and detailed execution, particularly in early-stage of first-in-function roles 
• Track record of influencing development, regulatory, and portfolio decisions at senior and governance levels 
• Experience managing and transitioning work from external consultants and vendors to internal teams 
• A collaborative, ethical, and inclusive leadership style with the ability to inspire followership and alignment across functions  
• Ability to travel domestically up to 10-15% for internal and external meetings 

This role follows a hybrid schedule, with an expectation to be onsite at our South San Francisco headquarters at least three days per week 

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 base salary range for employees located in the San Francisco Bay Area is determined by credentials and qualifications: 

• Non-MD candidates: $288,000 – $352,000 

• MD candidates: $342,000 – $418,000 

The MD salary range reflects additional medical training and responsibilities associated with medical review, safety signal evaluation, and safety governance. 

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