Clinical Trial Manager, CKD
Maze Therapeutics
Summary
As a Clinical Trial Manager (CTM) at Maze Therapeutics, you'll play a hands-on role in co-leading and driving the execution of our Chronic Kidney Disease (CKD) clinical trials. You'll have the opportunity to contribute to mid to late-stage clinical studies, work cross-functionally with internal teams and external partners, and ensure trials run efficiently and with the highest quality standards.
Job description
The Impact You'll Have
- Steer the execution of one or more of our Phase 2 CKD clinical trials; from protocol development to achievement of corporate and study milestones such as first patient in, interim analysis, database lock, and study report completion.
- Manage external vendors including CROs, additional key vendors, and global investigative sites.
- Ensure adherence to study protocols, SOPs, ICH GCP guidelines by overseeing monitoring activities at investigative sites.
- Coordinate the development of study materials such as CRFs, ICFs, patient diaries.
- Act as the voice of Clinical Operations on cross-functional teams, including the Study Execution Team (SET).
- Partner with Clinical Operations and Clinical Science Team to engage with therapeutic area KOLs and Investigators.
What We're Looking For
- A degree in a scientific discipline or health related field.
- Minimum of 4 years clinical research experience, including 2 years as a Clinical Trial Manager at a biopharmaceutical company or CRO.
- Experience with planning and executing Phase I-II trials is preferred.
- Demonstrated proficiency in implementing, monitoring, and management of clinical trials, from start-up to close-out.
- General knowledge of FDA regulatory requirements and ICH GCP guidelines.
- Strong organizational skills, ability to prioritize and multi-task.
- Excellent verbal and written communication skills.
- Demonstrated problem-solving and negotiation abilities.
- Ability to work as part of a team and build strong working relationships with internal and external partners.
- Capacity to roll-up sleeves to perform a broad range of clinical trial related tasks as needed.
- Willingness to travel as necessary, consistent with project needs.
- Excellent computer proficiency (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook).
- Experience with clinical trial databases (e.g., Medidata Rave, Veeva, etc.).
Requirements
- A degree in a scientific discipline or health related field.
- Minimum of 4 years clinical research experience, including 2 years as a Clinical Trial Manager at a biopharmaceutical company or CRO.
- Experience with planning and executing Phase I-II trials is preferred.
- Demonstrated proficiency in implementing, monitoring, and management of clinical trials, from start-up to close-out.
- General knowledge of FDA regulatory requirements and ICH GCP guidelines.
- Strong organizational skills, ability to prioritize and multi-task.
- Excellent verbal and written communication skills.
- Demonstrated problem-solving and negotiation abilities.
- Ability to work as part of a team and build strong working relationships with internal and external partners.
- Capacity to roll-up sleeves to perform a broad range of clinical trial related tasks as needed.
- Willingness to travel as necessary, consistent with project needs.
- Excellent computer proficiency (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook).
- Experience with clinical trial databases (e.g., Medidata Rave, Veeva, etc.).
Benefits
- Medical, Dental & Vision
- Mental Health Offerings
- Equity Incentive Plan
- 401(k) Matching
- Holiday & PTO Policy
- 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.