Senior Clinical Trial Manager, Early Development South San Francisco, CA

BioSpace; South San Francisco (CA); On-site; USD 176,000 - 215,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

Equity incentive plan

401(k) with employer match

Generous holiday and PTO

Job summary

Maze Therapeutics is seeking a Senior Clinical Trial Manager to drive the execution of early development studies in a fast-paced, collaborative environment. You will coordinate with Clinical Pharmacology, Translational Medicine, and Clinical Science to ensure trials run on time, within budget, and in full compliance with ICH-GCP standards.

The role requires 5–8 years of clinical operations experience, including ≥4 years as CTM, and a willingness to travel 5–10%.

Qualifications

• Bachelor’s degree in a scientific field with 5–8 years of clinical operations experience, including ≥4 years as CTM.
• Experience leading Phase I and early development trials in healthy volunteers and patients.
• Strong understanding of clinical pharmacology, PK/PD, bioanalytical sampling and PK data workflows.
• Familiarity with regulatory guidelines (FDA, EMA, ICH-GCP) and study budgeting.
• Experience managing CROs, vendors, budgets, and cross-functional teams such as Clinical Pharmacology and Translational Medicine.
• Willingness to travel up to 5–10%.

Responsibilities

• Lead planning, execution, and delivery of early-phase trials from design to CSR completion.
• Own operational lead for assigned studies, driving milestones like FPI, enrollment, analyses, and database lock.
• Partner with internal teams to align plans with scientific/regulatory objectives.
• Oversee vendor selection, onboarding, and day-to-day oversight.
• Support budget tracking and vendor spend management.
• Ensure data integrity and regulatory readiness through CRO/site monitoring.

Skills

Clinical trial leadership

Vendor management

Budget management

Cross-functional collaboration

CTM experience

Regulatory knowledge

Travel readiness

Education

Bachelor's degree in science

Tools

Medidata RAVE

Veeva

CTMS

Job 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 a Senior Clinical Trial Manager (Sr. CTM) at Maze Therapeutics, you’ll play a hands‑on role in driving the execution of our clinical trials. You’ll have the opportunity to lead Early Development studies, work cross‑functionally with internal teams and external partners, and ensure studies 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

• Clinical Trial Execution & Leadership
  • Lead the planning, execution, and delivery of Clinical Pharmacology and early-phase trials (e.g., FIH, SAD/MAD, DDI, bioavailability/bioequivalence and renal/hepatic impairment studies) from study design through CSR completion.
  • Serve as the operational lead for assigned studies, managing cross-functional meetings and driving achievement of key milestones (FPI, enrollment completion, interim analyses, database lock, and CSR).
  • Collaborate closely with Clinical Pharmacology, Clinical Science, and Translational Medicine to align operational plans with scientific and regulatory objectives.
  • Lead study feasibility assessments and contribute to dose escalation strategy, cohort planning, and adaptive study design considerations to ensure timely and efficient execution.
  • Partner with Clinical Science and Clinical Pharmacology lead to engage therapeutic area experts and KOLs, support advisory board meetings, and provide input on study rationale and design.
• Vendor, CRO & Site Management
  • Lead and facilitate request for proposals from CROs and clinical trial vendors through final vendor selection as well as budget and contract negotiations.
  • Oversee CRO and vendor onboarding, and day‑to‑day oversight, ensuring adherence to budgets, protocols, and ICH‑GCP guidelines.
• Budget & Financial Oversight
  • Support Clinical Operations Leadership with study‑specific budget tracking and vendor spend management.
• Data Quality, Compliance & Regulatory Readiness
  • Ensure clinical trial data integrity and adherence to protocols, SOPs, and ICH‑GCP guidelines through oversight of CROs, vendors, and site monitoring activities.
• Process Optimization & Technology Implementation
  • Contribute to evaluating and implementing clinical trial systems (e.g., eTMF, CTMS) to enhance efficiency.
  • Assist in developing SOPs and scalable processes for clinical operations.
• Cross‑functional Collaboration
  • Partner with internal teams, such as CMC and Clinical Supply Chain, to manage study drug supply and distribution. Work closely with other functions to ensure smooth study execution.

What We’re Looking For

• A Bachelor’s degree in a scientific discipline or health related field with 5–8 years of clinical operations experience, including at least 4 years as a CTM, with hands‑on experience managing Clinical Pharmacology or early‑phase studies.
• Demonstrated experience managing Phase I and early development trials across healthy volunteer and patient populations, including first‑in‑human and bridging studies.
• Strong understanding of Clinical Pharmacology principles, including pharmacokinetics, pharmacodynamics, bioanalytical sampling, and PK data workflows.
• Familiarity with regulatory guidelines (FDA, EMA, ICH‑GCP)
• Experience conducting a broad range of clinical trial related activities including study start‑up to study close‑out, clinical trial databases (e.g., Medidata RAVE, Veeva), knowledge of clinical trial budgeting, and managing CROs and vendors.
• Strong executional leadership, problem‑solving skills, and ability to manage cross‑functional teams at the study level.
• A startup mindset, willingness to roll up sleeves, and ability to work in a fast‑paced, evolving, and collaborative team environment.
• Excellent communication skills and the ability to manage cross‑functional relationships effectively.
• Are willing to travel up to 5‑10% 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 $176,000 - $215,000. 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.