current openings

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 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 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