Clinical Operations Director

We are seeking an innovative and self-motivated Director of Clinical Operations to help lead clinical development of our advanced cell therapy programs. Reporting to the Chief Development Officer, you will oversee and directly contribute to the execution and strategy of the company’s global clinical trials. You will be key to establishing investigator, vendor, and cross-department partnerships while building our internal Clinical capacity as our pipeline advances. You’ll be joining a company committed to developing regenerative medicines that deliver life-changing, functional cures for patients living with serious diseases. This role could be based on-site in Vancouver, Canada or Fremont, California. 

Responsibilities

• Lead the end-to-end operational strategy, startup, execution, and closeout of global Phase I-III cell therapy clinical trials, flexing to support additional responsibilities assigned by leadership.
• Translate clinical development plans into actionable operational milestones, study budgets, resource plans, and risk-mitigation strategies.
• Direct cross-functional study execution teams—including Clinical Development, Regulatory, Quality, CMC, and Data Management—while championing cross-departmental knowledge sharing.
• Partner with CMC and Supply Chain to establish specialized cell therapy protocols, including chain-of-identity (COI), chain-of-custody (COC), cryogenic transport, and site handling.
• Author, review, and standardize trial-related documents, protocols, informed consents, Investigator's Brochures, study manuals, and Clinical Operations SOPs.
• Drive international site identification, feasibility, qualification, and activation, targeting specialized academic medical centers, endocrinology units, and cell therapy treatment centers.
• Manage clinical portions of regional regulatory submissions (FDA, EMA, Health Canada, MHRA) and ethics approvals in collaboration with Regulatory Affairs and local CRO partners.
• Develop country-specific patient recruitment and retention strategies tailored to target populations.
• Identify, build, and nurture key opinion leader (KOL) and site investigator partnerships.
• Lead vendor selection (RFPs, bid defenses, negotiations) and maintain active oversight, performance governance, scope tracking, and quality management for CROs, central labs, and specialty providers.
• Create, negotiate, review, and approve clinical trial, vendor, site, and department budgets, as well as invoices, change orders, and accruals in partnership with Finance.
• Build and scale the Clinical department by establishing foundational SOPs, setting up eTMF structures, and hiring, training, and managing team members.
• Ensure all trial activities, sites, eTMF systems, and vendor records maintain inspection readiness and comply with ICH-GCP guidelines and global cell/gene therapy regulations