Associate Director, Clinical Operations bei Kyverna

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The Kyverna therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Be at the forefront of cell therapy innovation by joining scientists, industry veterans and healthcare visionaries and help transform how autoimmune diseases are treatedTitle: Associate Director, Clinical OperationsLocation: Hybrid (2-days Emeryville, CA) or Remote eligibleReporting to: Sr. Director, Clinical Operations 

Responsibilities

Independently lead and manage all aspects of clinical trials from feasibility through closeout.

Drive direction, planning and execution of assigned clinical trial and be able to effectively problem solve

Oversee CROs and vendors; serve as first escalation point and drive issue resolution.

Make informed study-level decisions using stakeholder input; consult Oversight Director as needed.

Select and manage CROs and vendors for new trials.

Ensure regulatory and company compliance across clinical trials.

Monitor trial budgets, invoices, and financial accruals.

Develop and manage study timelines aligned with corporate objectives.

Facilitate cross-functional communication within study teams.

Ensure trial oversight in line with SOPs, guidelines, and best practices.

Identify and escalate risks affecting quality, timelines, budget, data, or patient safety.

Mentor and support the professional development of trial managers, CRAs, and CTAs.

Contribute to demand planning and trial forecasting.

Drive enrollment planning, timelines, forecasting, and associated costs.

Design and implement effective patient recruitment strategies.

Qualifications

Bachelor’s degree in Life Sciences or Healthcare required; advanced degree preferred.

Minimum of 8 years of progressive experience in clinical trial management, including CRO oversight; 4+ years of line management experience preferred.

Proven experience in global study management, including registrational and/or Phase 3 trials.

Sponsor experience required; CAR T and regulatory inspection readiness experience preferred.

Strong multitasking and problem-solving abilities with sound judgment in complex situations.

Excellent influencing skills to engage internal and external partners and drive clinical trial programs forward.

Demonstrated expertise in project management and effective decision-making.

Deep understanding of clinical trial enrollment dynamics within specific indication areas.

In-depth knowledge of clinical trial budgets, including CRO/vendor and site budgets.

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