Director, Clinical Operations
Core
Lead end-to-end operational strategy, startup, execution, and closeout of global Phase I-III cell therapy clinical trials for advanced regenerative medicine programs.
Role type
Director, Clinical Operations (Cell Therapy)
Builds
Global clinical trials for cell/gene therapy products targeting endocrine and metabolic diseases
Domain
Biotechnology / Cell & Gene Therapy / Regenerative Medicine
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global clinical trial management (Phase I-III), Cell therapy logistics (COI, COC, cryogenic transport), Vendor/CRO management, Budget management, Regulatory submissions (FDA/EMA/Health Canada), Site identification and activation, Patient recruitment strategies, SOP development, Team building
Preferred skills
Masters degree in Life Sciences/Nursing, Experience with first-in-human trials, Surgical route administration experience, Early-stage biotech environment experience
Technologies
eTMF systems, Clinical trial management systems
Responsibilities
Translate clinical development plans into operational milestones and risk-mitigation strategies; Direct cross-functional study execution teams; Partner with CMC/Supply Chain for specialized protocols; Author and standardize trial documents; Drive international site identification and activation; Manage regional regulatory submissions and ethics approvals; Develop patient recruitment strategies; Lead vendor selection and performance governance; Manage clinical budgets; Build and scale the Clinical department; Ensure inspection readiness and compliance with ICH-GCP
Seniority
Director, strategic leadership with hands-on execution
