Senior Clinical Trials Lead — Early-Phase Gene Therapy (Remote)

Arbor Biotechnologies; United States; À distance; USD 165 000 - 185 000; Plein temps

Avantages offerts par ce poste

Bonus eligibility

New hire equity

Comprehensive health coverage

Discretionary paid time off

Résumé du poste

Arbor Biotechnologies is seeking a Senior Clinical Trial Manager to lead day‑to‑day operations for early‑phase gene-editing programs in rare genetic diseases. You will oversee start‑up through close‑out, manage sites, CROs, vendors, timelines, and budgets, and ensure documentation and inspection readiness, while partnering with internal and external teams.

The role requires hands‑on leadership, collaboration across multiple functions, and global trial oversight, including regulatory submissions

Qualifications

• Bachelor’s degree in a scientific, health-related, or related field.
• 6+ years of progressive clinical operations experience in pharma/biotech, including start‑to‑close trial execution.
• Experience managing early‑phase studies; rare disease or CNS experience preferred.
• Experience managing U.S. and global trials across CROs, vendors, labs, and sites.
• Familiarity with ethics committee and regulatory submissions (pre‑IND/IND/CTA or similar).
• Strong knowledge of GCP, ICH guidelines, and drug development processes.
• Experience with vendor oversight, budgets, contracts, invoices, and change orders.
• Strong clinical ops leadership, planning, and organizational skills.
• Knowledge of mRNA, RNAi, gene therapy or gene‑editing therapeutics; LNP/AAV familiarity preferred.
• Ability to work independently and collaboratively in a fast-paced startup environment.

Responsabilités

• Lead day-to-day clinical trial operations across studies, sites, CROs, labs, and vendors.
• Manage start‑up, site activation, monitoring oversight, and close‑out activities.
• Own and manage study timelines, budgets, invoices, vendor deliverables, and milestones.
• Oversee study documentation and trial master file quality for inspection readiness.
• Review operational documents such as protocols, ICFs, CRFs, SAPs, CSRs, and study plans.
• Partner with cross-functional teams to drive execution and milestones.
• Manage clinical sample logistics between patients, sites, and labs.
• Drive timelines for Safety Review Boards, DMCs, data cuts, and related activities.
• Lead or support vendor review, contracting, onboarding, and oversight.
• Build relationships with sites, CROs, vendors, and internal stakeholders; plan investigator meetings.
• Identify and mitigate study risks and operational issues.
• Represent the company externally with study partners and sites.
• Travel domestically and internationally as needed.

Connaissances

Clinical trial operations leadership

Project coordination

Planning and organizational skills

Communication skills

Stakeholder management

Smartsheet or Office proficiency

Formation

Bachelor’s degree in a scientific/health-related field

Outils

Smartsheet

Microsoft Office

Description du poste

Arbor Biotechnologies is seeking a Senior Clinical Trial Manager to lead day‑to‑day operations for early‑phase gene-editing programs in rare genetic diseases. You will oversee start‑up through close‑out, manage sites, CROs, vendors, timelines, and budgets, and ensure documentation and inspection readiness, while partnering with internal and external teams.

The role requires hands‑on leadership, collaboration across multiple functions, and global trial oversight, including regulatory submissions