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

Annual performance bonus

Job summary

Maze Therapeutics is seeking a Senior Clinical Trial Manager to lead early‑phase studies and drive efficient execution across cross‑functional teams.

You will own study design through CSR, manage vendors and budgets, ensure data integrity, and advance regulatory readiness, with travel up to 5–10% in the San Francisco Bay Area.

Qualifications

• Bachelor’s degree in a scientific field; 5–8 years in clinical operations, including at least 4 years as CTM.
• Experience managing Phase I and early development trials across healthy volunteers and patients.
• Strong understanding of Clinical Pharmacology, PK/PD, bioanalytical sampling, and PK data workflows.
• Familiarity with FDA, EMA, ICH-GCP regulatory guidelines.
• Experience budgeting, CRO/vendor management, and overseeing study start-up to close-out.
• Demonstrated leadership, problem-solving, and cross-functional collaboration; ability to thrive in a fast-paced startup environment.
• Excellent communication and travel up to 5–10%.

Responsibilities

• Lead planning, execution, and delivery of early-phase trials from design to CSR.
• Serve as operational lead, coordinating cross-functional meetings and milestones.
• Collaborate with Clinical Pharmacology and Translational teams to align plans with scientific goals.
• Oversee CRO/vendor selection, onboarding, and budget management.
• Ensure data integrity and adherence to ICH-GCP through monitoring activities.
• Evaluate and implement CTMS/eTMF systems to improve efficiency.
• Coordinate study drug supply with Clinical Supply Chain; travel up to 10%.

Skills

CTM leadership

Cross-functional leadership

Budget management

Vendor management

Study start-up

Regulatory knowledge

Problem solving

Communication skills

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.