Director, Clinical Trial Operations

About the role

The Director of Clinical Trial Operations will partner with the Executive Director of Clinical Operations and cross‑functional leaders to plan, execute, and deliver one or more clinical trial programs. This senior position provides operational leadership, decision‑making authority, and mentorship to ensure trials meet corporate goals, timelines, budgets, and quality standards.

Key responsibilities

• Lead overall study or program deliverables, maintaining strategic oversight throughout the trial lifecycle.
• Coordinate activities across study phases, including planning, site qualification, monitoring, data review, cleaning, and closeout.
• Maintain study timelines and proactively identify issues impacting budget, resources, or schedules.
• Develop and execute risk‑management and mitigation plans.
• Drive cross‑functional alignment and manage internal and external resources such as CROs and site personnel.
• Ensure compliance with SOPs, GCP, ICH, FDA, and other global regulatory requirements.
• Provide mentorship and line‑management to junior clinical operations staff.

Required profile

• Extensive experience leading clinical trial operations in a biotechnology or pharmaceutical environment.
• Demonstrated ability to manage complex, multi‑site studies and deliver results on time and within budget.
• Strong leadership and communication skills to influence internal teams and external partners.
• Track record of fostering cross‑functional collaboration and ensuring regulatory compliance.

Required skills

• In‑depth knowledge of Good Clinical Practice (GCP), ICH guidelines, and FDA regulatory requirements.
• Familiarity with clinical trial Standard Operating Procedures (SOPs) and risk‑management processes.