Clinical Operations Regional Lead

Regional Lead, Clinical Operations (Oncology - Early Phase Trials)
Location: Flexible

A leading biotech company focused on precision oncology is seeking a Regional Lead of Clinical Operations to join their dynamic team. This is a unique opportunity to play a pivotal role in the execution of early-stage clinical trials and help shape the future of cancer treatment.

About the Role:

As a Regional Lead, you will oversee the operational execution of one or more clinical trials from start-up through close-out. You'll collaborate cross-functionally with internal teams and external partners to ensure trials are delivered on time, within budget, and in compliance with global regulatory standards.

Key Responsibilities:

• Support Study Leads and cross-functional Study Execution Teams (SETs) in trial planning and execution.
• Manage CROs and clinical vendors, including RFPs, bid defenses, and contract oversight.
• Contribute to the development and review of clinical documents (protocols, ICFs, CRFs, study manuals).
• Oversee clinical systems (CTMS, TMF, EDC, IRT) and ensure inspection readiness.
• Conduct clinical data review and site management in collaboration with CROs.
• Monitor study metrics, identify risks, and implement mitigation strategies.
• Foster strong relationships with investigators, site staff, and internal stakeholders.
• Participate in audits and regulatory inspections as needed.

Qualifications:

• Bachelor's degree in life sciences or related field.
• 6+ years of experience in clinical operations and drug development.
• Strong knowledge of FDA, ICH/GCP regulations, and global clinical trial management.
• Experience in early-phase oncology trials, including precision medicine, is preferred.
• Excellent organizational, analytical, and communication skills.
• Proactive, detail-oriented, and a collaborative team player.
• Willingness to travel up to 20 percent.