Senior Clinical Trial Lead, Early-Phase & Cross-Functional

BioSpace; South San Francisco (CA); On-site; USD 176,000 - 215,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

Equity incentive plan

401(k) with employer match

Generous holiday and PTO

Job summary

Maze Therapeutics is seeking a Senior Clinical Trial Manager to drive the execution of early development studies in a fast-paced, collaborative environment. You will coordinate with Clinical Pharmacology, Translational Medicine, and Clinical Science to ensure trials run on time, within budget, and in full compliance with ICH-GCP standards.

The role requires 5–8 years of clinical operations experience, including ≥4 years as CTM, and a willingness to travel 5–10%.

Qualifications

• Bachelor’s degree in a scientific field with 5–8 years of clinical operations experience, including ≥4 years as CTM.
• Experience leading Phase I and early development trials in healthy volunteers and patients.
• Strong understanding of clinical pharmacology, PK/PD, bioanalytical sampling and PK data workflows.
• Familiarity with regulatory guidelines (FDA, EMA, ICH-GCP) and study budgeting.
• Experience managing CROs, vendors, budgets, and cross-functional teams such as Clinical Pharmacology and Translational Medicine.
• Willingness to travel up to 5–10%.

Responsibilities

• Lead planning, execution, and delivery of early-phase trials from design to CSR completion.
• Own operational lead for assigned studies, driving milestones like FPI, enrollment, analyses, and database lock.
• Partner with internal teams to align plans with scientific/regulatory objectives.
• Oversee vendor selection, onboarding, and day-to-day oversight.
• Support budget tracking and vendor spend management.
• Ensure data integrity and regulatory readiness through CRO/site monitoring.

Skills

Clinical trial leadership

Vendor management

Budget management

Cross-functional collaboration

CTM experience

Regulatory knowledge

Travel readiness

Education

Bachelor's degree in science

Tools

Medidata RAVE

Veeva

CTMS

Job description

Maze Therapeutics is seeking a Senior Clinical Trial Manager to drive the execution of early development studies in a fast-paced, collaborative environment. You will coordinate with Clinical Pharmacology, Translational Medicine, and Clinical Science to ensure trials run on time, within budget, and in full compliance with ICH-GCP standards.

The role requires 5–8 years of clinical operations experience, including ≥4 years as CTM, and a willingness to travel 5–10%.