Senior Clinical Trial Manager, Early Development South San Francisco, CA
BioSpace · South San Francisco, CA · 1 mo ago
HybridAnalyst$176k–$215k/yrFull-time
About the Role
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.
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,