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Salary: CAD 185,000 - 270,000 / annual
Aspect Biosystems is seeking a Director of Clinical Operations to lead the clinical development of advanced cell therapy programs. Reporting to the Chief Development Officer, you will oversee the end-to-end execution and strategy of global clinical trials (Phase I-III), establish key partnerships with investigators and vendors, and build internal clinical capacity as the pipeline advances.
Key responsibilities include:
- Lead operational strategy, startup, execution, and closeout of global Phase I-III cell therapy clinical trials
- Translate clinical development plans into actionable operational milestones, budgets, resource plans, and risk-mitigation strategies
- Direct cross-functional study execution teams (Clinical Development, Regulatory, Quality, CMC, Data Management) and champion knowledge sharing
- Partner with CMC and Supply Chain on specialized cell therapy protocols including chain-of-identity, chain-of-custody, cryogenic transport, and site handling
- Author, review, and standardize trial-related documents (protocols, informed consents, Investigator's Brochures, SOPs)
- Drive international site identification, feasibility, qualification, and activation targeting academic medical centers and cell therapy treatment centers
- Manage clinical portions of regional regulatory submissions (FDA, EMA, Health Canada, MHRA) and ethics approvals
- Develop country-specific patient recruitment and retention strategies
- Identify and nurture key opinion leader (KOL) and site investigator partnerships
- Lead vendor selection (RFPs, negotiations) and maintain oversight of CROs, central labs, and specialty providers
- Create, negotiate, and approve clinical trial, vendor, site, and department budgets
- Build and scale the Clinical department by establishing SOPs, eTMF structures, and hiring/training team members
- Ensure all trial activities, sites, systems, and vendor records maintain inspection readiness and comply with ICH-GCP guidelines and global cell/gene therapy regulations
Requirements:
- Bachelor's degree in Life Sciences, Nursing, or related scientific discipline (Master's degree highly beneficial)
- 8 years of related experience in clinical trial conduct with progressively increasing responsibilities; 4+ years in a leadership position (less experienced, driven individuals will be considered)
- Previous experience developing cell or gene therapy products including rare diseases
- Experience leading early clinical development programs including first-in-human trial launches
- Experience in early-stage, fast-paced biotechnology environments with lean internal teams
- Experience with surgical route of administration for investigational products
- Solid understanding and application of ICH Guidelines, Code of Federal Regulations, and GCP
- Proven working knowledge of cell therapy logistics and operationalizing multi-center, multi-national Phase I-III trials
- Strong experience issuing RFPs, selecting CROs and specialty vendors, and managing complex program budgets
- Deep understanding of global regulatory frameworks governing advanced therapy medicinal products (ATMPs) and cellular therapy regenerative medicines
- Results-driven, sense of urgency, thrives in fast-paced, interdisciplinary, entrepreneurial environments
- Highly adaptable and agile when faced with change, ambiguity, and competing priorities
- Strong multi-disciplinary team collaboration skills
