Associate Director Clinical Operations

Currently partnered with a start-up I&I biotech that's searching for an Associate Director, Clinical Operations to join their team remotely, full time.

The Associate Director, Clinical Operations is responsible for providing operational leadership for the planning, execution, and oversight of clinical trials, ensuring studies are conducted in accordance with protocol requirements, regulatory standards, timelines, budgets, and company objectives. This role serves as a key partner to Clinical Development and other cross-functional stakeholders, overseeing CROs, vendors, and study teams while driving operational excellence across one or more development programs.

Reporting to the Senior Director, Clinical Operations, the Associate Director/Director will play a critical role in advancing the company's clinical pipeline and helping build scalable clinical development capabilities within a dynamic biotechnology environment.

Responsibilities:

• Lead the operational planning, execution, and oversight of clinical trials from study start-up through closeout, ensuring delivery against timelines, budgets, quality standards, and program objectives.
• Provide leadership to cross-functional study teams and serve as the primary Clinical Operations representative across assigned development programs.
• Develop and implement study operational strategies, including timelines, enrollment plans, resource forecasts, risk mitigation plans, and study management processes.
• Oversee CROs, central laboratories, and other external vendors, ensuring high-quality performance, budget adherence, and achievement of key study milestones.
• Partner with Clinical Development, Regulatory Affairs, Data Management, Biostatistics, Clinical Supply, Quality, and other stakeholders to support effective study execution and decision-making.
• Contribute to the development and review of clinical protocols, informed consent forms, study plans, and other critical clinical trial documentation.
• Monitor study progress, key performance indicators, enrollment trends, and operational risks, implementing corrective actions as necessary to maintain program objectives.

Education and Experience:

• Bachelor's degree required, preferably in Life Sciences, Nursing, or a related scientific discipline; advanced degree preferred.
• Minimum of 10-12 years (Associate Director) or 15 years (Director) of progressive clinical research and clinical operations experience within the pharmaceutical, biotechnology, or CRO industry.
• Demonstrated hands-on experience leading Phase 2 and/or Phase 3 clinical trials in a sponsor environment.
• Proven experience managing CROs, vendors, study budgets, timelines, and operational deliverables.
• Strong understanding of all aspects of the clinical trial lifecycle, including study design, start-up, conduct, monitoring oversight, database lock, and closeout.
• Hands-on experience managing multinational clinical trials across North America, Europe, Asia-Pacific, and/or other global regions.
• Experience in immunology, inflammation, rare disease, or other specialty therapeutic areas is highly desirable.