Associate Director, Clinical Operations

$185,000 - $210,000/Yr

Kyverna Therapeutics - Emeryville, CA

Full-time - Senior

Emeryville, CA

Administrative and Support Services

About the position

The Associate Director, Clinical Operations at Kyverna Therapeutics is responsible for managing clinical trials in coordination with a clinical operations team. This role involves overseeing daily operations of clinical programs, leading a team of clinical operations professionals, and ensuring compliance with regulatory guidelines. The position requires strong leadership, strategic management, and effective communication skills to facilitate relationships with internal and external stakeholders while achieving project goals on time and within budget.

Responsibilities

• Manage complex Phase 1, 2, 3, and 4 clinical trials as part of a small operational team.
• Demonstrate oversight of vendors and work in a quality framework that supports early and late development work.
• Responsible for vendor management activities including attendance and input at team meetings and tracking and follow up on action items.
• Lead study start up process and cross functional planning in support of study start up.
• Provide review and input on clinical documents (protocols, informed consent documents, monitoring plans, clinical trials report, investigator brochures, etc.).
• Conduct feasibility and site selection.
• Coordinate closely with Clinical Development, Biostatistics, Data Management, Drug Safety, Legal, Finance, Project Management and Regulatory to ensure operational excellence.
• Prepare clinical research budgets and timelines.
• Analyze and develop action plans to address issues with investigational sites, CRAs, and CROs.

Requirements

• Strong knowledge in the areas of drug development, operations, and strategic planning, specifically management of clinical trial operations.
• Demonstrated experience in study start up and vendor oversight.
• Experience with rare disease clinical trials is a plus.
• Demonstrated knowledge of international clinical pharmaceutical standards, ICH/GCP guidelines, and regulatory compliance.
• International experience is highly preferred.
• Must have experience managing CROs, central laboratories, and other clinical study vendors.
• Must have a working knowledge of data management, data review and analysis, and drug safety and Pharmacovigilance.
• Ability to work on and solve complex problems.
• Ability to prioritize and handle multiple tasks simultaneously.
• Excellent communication/interaction skills and experience in a dynamic, small organization.

Nice-to-haves

• Experience with rare disease clinical trials.

Benefits

• Stock options
• Bonus eligibility
• Comprehensive benefits package