Senior Clinical Trial Manager

About the role.

The Senior Clinical Trial Manager will lead day-to-day clinical trial operations for assigned early-phase studies of our gene-editing therapeutics in rare genetic diseases. Reporting to the Senior Director of Clinical Operations, this role will be responsible for study execution from start-up through close-out, including site oversight, CRO and vendor management, trial documentation, timelines, budgets, and operational issue resolution.

In our lean biotech environment, this role requires a hands-on clinical operations leader who can manage multiple aspects of trial execution while partnering closely with internal teams, investigative sites, CROs, laboratories, and external vendors.

What you'll do.
• Lead day-to-day clinical trial operations across assigned studies, sites, CROs, laboratories, and vendors.
• Manage study start-up, site activation, monitoring oversight, and close-out activities.
• Own and manage study timelines, budgets, invoices, vendor deliverables, and key milestones.
• Oversee study documentation and trial master file quality to support inspection readiness.
• Review and provide operational leadership on clinical documents, including protocols, ICFs, CRFs, SAPs, CSRs, study plans, and related materials.
• Partner with cross-functional study teams to drive study execution, resolve operational issues, and support achievement of study milestones.
• Manage clinical sample logistics between patients, sites, and laboratory vendors.
• Drive timelines and logistics for Safety Review Boards, Data Monitoring Committees, data cuts, and related study activities.
• Lead or support vendor review, selection, contracting, onboarding, and performance oversight.
• Build and manage effective relationships with investigative sites, CROs, vendors, clinical experts, and internal stakeholders, including planning investigator meetings.
• Identify, escalate, and resolve study risks and operational issues.
• Represent the company externally with study partners and investigative sites.
• Travel domestically and internationally to investigative sites or study-related meetings as needed.

What you bring.
• Bachelor's degree in a scientific, health-related, or related field.
• 6+ years of progressive clinical operations experience in the pharmaceutical and/or biotechnology industry, including experience managing clinical trial execution from start-up through close-out.
• Experience managing early-phase clinical studies; rare disease or CNS experience preferred.
• Experience managing U.S. and global clinical trials across CROs, vendors, laboratories, and study sites.
• Familiarity with ethics committee and regulatory submissions, such as pre-IND, IND, Scientific Advice, CTA, or similar filings.
• Strong knowledge of GCP, ICH guidelines, clinical research regulations, and the drug development process.
• Experience with vendor oversight, budgets, contracts, invoices, and change orders.
• Strong clinical operations leadership, project coordination, planning, and organizational skills.
• Proficiency with Smartsheet, Microsoft Office, or similar project and study tracking tools.
• Clear communication skills and the ability to work effectively with internal and external stakeholders.
• Knowledge of mRNA, RNAi, gene therapy, or gene-editing therapeutics; familiarity with LNP or AAV-based development preferred.
• Ability to work independently and collaboratively in a fast-paced environment.
• Hands-on mindset and willingness to work across multiple areas of clinical operations in a startup environment.
• Fully remote role

Compensation and benefits.

The anticipated base salary range for this position is $165,000-$185,000. Actual compensation will be determined based on several factors, including relevant experience, skills, education, training, internal equity and other job-related factors. All employees are eligible for bonus, new hire equity, comprehensive health coverage, and discretionary paid time off.