BioSpace
Senior Clinical Trial Manager, Early Development
BioSpace, South San Francisco, California, us, 94083
Senior Clinical Trial Manager, Early Development
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), 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.
Impact You’ll Have
Clinical Trial Execution & Leadership
Lead 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.
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, budget and contract negotiations.
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 CRO and vendor oversight.
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 for smooth study execution.
What We’re Looking For
A Bachelor’s degree in a scientific discipline or health‑related field with 5–8 years of clinical operations experience, including at least 4 years as a CTM, with hands‑on experience managing Clinical Pharmacology or early‑phase studies.
Demonstrated 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 PK, PD, 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 close‑out, clinical trial databases (e.g., Medidata RAVE, Veeva), knowledge of clinical trial budgeting, and 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 Maze offers a robust benefits package to eligible employees, including competitive medical, dental, vision, mental health offerings, equity incentive plan, 401(k) program with employer match, and generous holiday and PTO policy.
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Impact You’ll Have
Clinical Trial Execution & Leadership
Lead 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.
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, budget and contract negotiations.
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 CRO and vendor oversight.
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 for smooth study execution.
What We’re Looking For
A Bachelor’s degree in a scientific discipline or health‑related field with 5–8 years of clinical operations experience, including at least 4 years as a CTM, with hands‑on experience managing Clinical Pharmacology or early‑phase studies.
Demonstrated 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 PK, PD, 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 close‑out, clinical trial databases (e.g., Medidata RAVE, Veeva), knowledge of clinical trial budgeting, and 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 Maze offers a robust benefits package to eligible employees, including competitive medical, dental, vision, mental health offerings, equity incentive plan, 401(k) program with employer match, and generous holiday and PTO policy.
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