Senior Clinical Trial Manager, Early Development
Maze Therapeutics
Summary
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.
Job description
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.
Requirements
- Bachelor's degree in a scientific discipline or health related field
- 5–8 years of clinical operations experience
- At least 4 years as a Clinical Trial Manager (CTM)
- Hands-on experience managing Clinical Pharmacology or early-phase studies
- 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
- 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, 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
- Willingness to travel up to 5-10% to support study needs
Benefits
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Mental Health Offerings
- Equity Incentive Plan
- 401(k) With Employer Match
- Holiday Leave
- Paid Time Off
- Annual Performance Bonus
Company overview
Maze Therapeutics is a clinical-stage biopharmaceutical company that leverages human genetics to develop precision medicines for common diseases with significant unmet medical needs. Founded in 2017 and headquartered in South San Francisco, California, the company has developed Maze Compass™, a proprietary platform that integrates genetic variant functionalization into therapeutic development. Maze focuses on renal, cardiovascular, metabolic diseases, and obesity, with a pipeline that includes MZE829 (an APOL1 inhibitor in Phase II trials for APOL1-mediated kidney disease), MZE782 (an SLC6A19 inhibitor in Phase I for chronic kidney disease), and MZE001 (a glycogen synthase 1 inhibitor for Pompe disease). The company employs approximately 125 professionals and operates with a strategy that includes independent development, pharmaceutical collaborations, and company formation. Maze's approach combines genetic insights with small molecule drug development to create targeted therapies for patient populations with limited treatment options.