Maze Therapeutics · 2 weeks ago
Senior Clinical Trial Manager, PKU
South San Francisco, CA
Full-time
Hybrid
Senior Level
$176K/yr - $215K/yr
5+ years expMaze Therapeutics is a clinical-stage biopharmaceutical company focused on precision medicine for patients with renal, cardiovascular, and metabolic diseases. The Senior Clinical Trial Manager will lead the execution of clinical trials, ensuring high-quality standards and collaboration across teams, while managing vendor relationships and trial operations effectively.
BiopharmaBiotechnologyGeneticsTherapeutics
Hiring Manager
Kim Buck
Responsibilities
Co-lead operational activities of a mid-stage clinical trial, ensuring high-quality execution from study design to completion. Manage a Study Execution Team (SET) alongside the Study Lead, from protocol development to completion of key study milestones (FPI, enrollment completion, interim analysis, database lock, and final CSR)
Maintain active, hands-on oversight of CRO operations by closely tracking study progress, evaluating risks, and intervening early to course-correct
Apply a solution-oriented mindset to optimize study processes, boost study recruitment, and strengthen vendor/site performance
Provide strategic sponsor oversight of the global CRO monitoring team, guiding the CRO Global CTM and CRAs to ensure alignment with study timelines, recruitment targets, and high-quality data delivery. Initiate methods to better build relationships with sites, address issues, and ensure on-track enrollment and data entry
Lead end-to-end vendor management for all clinical trial vendors, including vendor identification and selection, budget and contract negotiations, onboarding, and ongoing operational oversight, ensuring compliance with study protocols, contracted scope, and ICH-GCP requirements
Develop and manage study-specific plans including site monitoring strategies, blinding plan, etc. Experienced in organizing DMCs, managing clinical trial budgets, and review clinical data listings and summary tables
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
Partner with Quality Assurance on inspection readiness efforts
Contribute to evaluating and implementing clinical trial systems (e.g., eTMF, CTMS, RBM) to enhance efficiency
Assist in developing SOPs and scalable processes for clinical operations
Partner with cross-functional teams like Biostatistics and Clinical science to identify and onboard new study vendors and systems (e.g. ARGUS)
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
5–8 years of clinical operations experience
At least 4 years as a CTM
Hands-on experience managing Phases I–III clinical trials
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
Experience with clinical trial databases (e.g., Medidata RAVE, Veeva)
Knowledge of clinical trial budgeting
Experience managing CROs and vendors
Strong executional leadership
Problem-solving skills
Ability to manage cross-functional teams at the study level
A startup mindset
Willingness to roll up sleeves
Ability to work in a fast-paced, evolving, and collaborative team environment
Excellent communication skills
Ability to manage cross-functional relationships effectively
Willingness to travel up to 30% to support study needs
Preferred
Global trial experience is a plus
Experience in common disease and/or rare disease drug development
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