Director/Senior Director, Clinical Operations
Core
Build and lead the operational foundation of a clinical development organization for kidney disease programs transitioning from discovery to IND-enabling and first-in-human activities.
Role type
Director/Senior Director, Clinical Operations
Builds
Scalable clinical operations processes, governance structures, vendor oversight models, and study management practices for rare kidney diseases.
Domain
Biotechnology / Clinical Development / Rare Diseases (ADPKD)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical operations strategy, CRO/vendor selection and management, rare disease patient identification and enrollment, global clinical trial design, preclinical-to-clinical transition planning, organizational design
Preferred skills
Experience in emerging biotechnology environments, experience with genetically defined patient populations, experience with nephrology investigator networks
Technologies
None explicitly stated
Responsibilities
Design and implement scalable clinical operations processes and governance structures; Establish frameworks for clinical trial execution as the organization grows; Lead selection and oversight of CROs, laboratories, and specialty vendors; Develop operational approaches for patient identification and enrollment in rare disease populations; Serve as the primary leader for transitioning programs from preclinical development into clinical execution.
Seniority
Senior Director, hands-on IC with strategic leadership
