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About the Role

As a Senior Clinical Trial Manager (Sr. CTM) at Maze Therapeutics, you’ll play a hands-on role in driving the execution of early Development studies. You’ll have the opportunity to lead studies, work cross-functionally with internal teams and external partners, and ensure studies run efficiently and with the highest quality standards.

Responsibilities

Lead the planning, execution, and delivery of Clinical Pharmacology and early-phase trials from study design through CSR completion.
Serve as the operational lead for assigned studies, managing cross-functional meetings and driving achievement of key milestones.
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.
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.
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.
Support Clinical Operations Leadership with study-specific budget tracking and vendor spend management.
Ensure clinical trial data integrity and adherence to protocols, SOPs, and ICH-GCP guidelines through oversight of CROs, vendors, and site monitoring activities.
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.
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.

Requirements

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.
Willing to travel up to 5-10% to support study needs.

Skills

Clinical Pharmacology
Early-phase trials
Study design
CSR completion
Operational lead
Cross-functional meetings
Milestone achievement
Clinical Science
Translational Medicine
Feasibility assessments
Dose escalation strategy
Cohort planning
Adaptive study design
Therapeutic area experts
KOL engagement
Advisory board meetings
Request for proposals (RFPs)
CRO management
Vendor management
Budget management
Contract negotiation
ICH-GCP guidelines
Budget tracking
Vendor spend management
Data integrity
Protocols
SOPs
Site monitoring
eTMF
CTMS
Process optimization
CMC
Clinical Supply Chain
Study drug supply
Distribution
Pharmacokinetics
Pharmacodynamics
Bioanalytical sampling
PK data workflows
Regulatory guidelines
FDA
EMA
Medidata RAVE
Veeva
Problem-solving
Cross-functional teams
Startup mindset
Communication skills

Location

South San Francisco

Work Type

Hybrid

Experience Level

Senior
5-8 years of clinical operations experience
At least 4 years as a CTM

Education Level

Bachelor’s degree in a scientific discipline or health related field

Salary/Compensations

$176,000 - $215,000
Eligible for an annual performance bonus

Benefits

Competitive medical, dental, and vision insurance
Mental health offerings
Equity incentive plan
401(k) program with employer match
Generous holiday and PTO policy

About the Company

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.
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, Impact Obsessed, Stand True.