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Salary: USD 165,000 - 185,000 / annual
Arbor Biotechnologies is a clinical-stage gene editing company based in Cambridge, MA, developing first-in-class genomic medicines for serious diseases including ALS and primary hyperoxaluria type 1. The company leverages advanced gene editing technologies to unlock new therapeutic targets.
The Senior Clinical Trial Manager will lead day-to-day clinical trial operations for assigned early-phase studies of gene-editing therapeutics in rare genetic diseases. Reporting to the Senior Director of Clinical Operations, this role owns study execution from start-up through close-out, including site oversight, CRO and vendor management, trial documentation, timelines, budgets, and operational issue resolution.
Key responsibilities include:
- 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 (protocols, ICFs, CRFs, SAPs, CSRs, study plans)
- Partner with cross-functional study teams to drive study execution and resolve operational issues
- Manage clinical sample logistics between patients, sites, and laboratory vendors
- Drive timelines and logistics for Safety Review Boards, Data Monitoring Committees, and data cuts
- Lead or support vendor review, selection, contracting, onboarding, and performance oversight
- Build and manage effective relationships with investigative sites, CROs, vendors, and internal stakeholders
- 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
This is a hands-on role in a lean biotech environment requiring close partnership with internal teams, investigative sites, CROs, laboratories, and external vendors.
Requirements:
- Bachelor's degree in a scientific, health-related, or related field
- 6+ years of progressive clinical operations experience in 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 (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 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
