Global Director, Clinical Operations - Cell Therapy

Aspect Biosystems Ltd.; Vancouver; Hybrid; CAD 264,000 - 385,000; Full time

Benefits offered by this job

Equity

Comprehensive benefits

Career progression

Job summary

Aspect Biosystems seeks a Director of Clinical Operations to lead and execute global Phase I-III cell therapy trials. This role reports to the Chief Development Officer and will drive operational strategy, study budgets, and cross-functional collaboration across Regulatory, Quality, and Data Management.

Base location can be Vancouver or Fremont. You will oversee site activation, vendor governance, and alignment with ICH-GCP and ATMP regulations while scaling the Clinical department and ensuring

Responsibilities

• Lead end-to-end operational strategy and execution of global Phase I-III cell therapy trials.
• Translate clinical development plans into actionable milestones, study budgets, resource plans and risk-mitigation strategies.
• Direct cross-functional study execution teams including Clinical Development, Regulatory, Quality, CMC, and Data Management.
• Partner with CMC and Supply Chain to establish cell therapy protocols including COI/COC, cryogenic transport, and site handling.
• Author, review, and standardize trial-related documents and SOPs.
• Drive international site identification, feasibility, qualification, and activation with academic medical centers and treatment centers.
• Manage regional regulatory submissions and ethics approvals with Regulatory Affairs and CRO partners.
• Develop country-specific patient recruitment and retention strategies.
• Identify and nurture key opinion leader (KOL) and site investigator partnerships.
• Lead vendor selection and governance for CROs, labs, and specialty providers.
• Create and manage budgets for clinical trials, vendors, sites, and departments with Finance.
• Build the Clinical department with SOPs, eTMF setup, and team hiring/training.
• Ensure trial activities, sites, eTMF systems, and vendors are inspection-ready and compliant with ICH-GCP and ATMP regulations.

Job description

Aspect Biosystems seeks a Director of Clinical Operations to lead and execute global Phase I-III cell therapy trials. This role reports to the Chief Development Officer and will drive operational strategy, study budgets, and cross-functional collaboration across Regulatory, Quality, and Data Management.

Base location can be Vancouver or Fremont. You will oversee site activation, vendor governance, and alignment with ICH-GCP and ATMP regulations while scaling the Clinical department and ensuring