Direct contract research organizations and vendors
Ensure gcp guidelines and regulatory compliance
The Director provides strategic leadership for the implementation and execution of clinical trials from study start-up through close-out
Job Summary
The Director provides strategic leadership for the implementation and execution of clinical trials from study start-up through close-out.
This role is accountable for directing contract research organizations, study vendors, and investigative sites while ensuring alignment with corporate objectives.
The position requires mentoring clinical operations personnel and establishing oversight processes for monitoring visit reports and protocol deviations.
Matching Summary
The Director provides strategic leadership for the implementation and execution of clinical trials from study start-up through close-out.
Skills & Requirements
Must-have
Lead cross-functional clinical study teams
Direct contract research organizations and vendors
Ensure GCP guidelines and regulatory compliance
Manage clinical trial budgets and timelines
Oversee protocol development and execution
Nice-to-have
Experience with allogeneic cell therapies
Foster culture of accountability and collaboration
Proactive risk identification and mitigation
Strong negotiation skills for vendor selection
Ability to travel up to 15%
Key Requirements
Leadership experience in clinical operations
Knowledge of FDA regulatory requirements
Expertise in GCP guidelines and SOPs
Experience managing CROs and vendors
Background in immunotherapy or cell therapy trials