Sr. Director, Clinical Operations
Core
Lead hands-on execution of early clinical development activities, specifically first-in-human Phase 1 studies, for a biological therapeutics company.
Role type
Senior Director, Clinical Operations (hands-on IC)
Builds
First-in-human clinical trials for antibody medicines
Domain
Biotechnology / Clinical Operations / Early-phase drug development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical operations planning, CRO/vendor management, global study start-up, Phase 1 execution, protocol feasibility, site strategy, budget management, regulatory coordination, ICH-GCP compliance, risk mitigation
Preferred skills
Antibody therapeutics experience, Australia clinical pathways, China regulatory pathways, biomarker/immunogenicity strategies, clinical operations infrastructure setup
Technologies
None explicitly listed
Responsibilities
Lead clinical operational planning and execution for early development programs; Develop integrated study plans, timelines, and budgets; Lead CRO and vendor selection and oversight; Develop and execute Phase 1 site strategy; Partner with Clinical Development and Medical leadership on protocols; Ensure studies comply with ICH-GCP and regulatory requirements; Establish scalable clinical operations processes and SOPs
Seniority
Senior Director, hands-on IC
