Maze Therapeutics · 2 weeks ago
Senior Clinical Trial Manager, Early Development
South San Francisco, CA
Full-time
Onsite
Senior Level
$176K/yr - $215K/yr
5+ years expMaze Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel precision medicines for patients with genetic diseases. As a Senior Clinical Trial Manager, you will lead the execution of early-phase clinical trials, manage cross-functional teams, and ensure compliance with regulatory standards while driving the success of clinical studies.
BiopharmaBiotechnologyGeneticsTherapeutics
Hiring Manager
Kim Buck
Responsibilities
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
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
Qualification
Required
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
Benefits
Competitive medical, dental, and vision insurance
Mental health offerings
Equity incentive plan
401(k) program with employer match
Generous holiday and PTO policy
Company
Maze Therapeutics
Maze Therapeutics is a biotechnology company that develops precision medicines for renal, cardiovascular, and metabolic diseases.
51-200 employees
H1B Sponsorship
Maze Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (3)
2023 (2)
2022 (5)
2021 (3)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$646MKey Investors
Matrix Capital ManagementCity Hill Ventures
2025-09-11Post Ipo Equity· $150M
2025-01-31IPO
2024-12-03Series D· $115M
Leadership Team
Jason Coloma
Chief Executive Officer
Misbah Tahir
Chief Financial Officer
Recent News
2026-01-06
Maze Therapeutics, Inc.
2025-11-09
StreetInsider.com
2025-11-07
Company data provided by crunchbase