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Kyverna - Therapeutics - Sr. Medical Director, Clinical Development

Remote2d ago

Remote Director WW Clinical Research Mental Health Clinical Director Physician Clinical Trials Documentation Training Development Clinical Documentation Reporting

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Requirements

• MD, DO, (or ex-US equivalent) or MD-PhD degree required. • 7+ years of clinical research experience with 4+ years of industry experience in late phase clinical development involved in the design and execution of clinical trials. Experience in late-stage clinical development preferred. • Specialty training in neurology, rheumatology, nephrology and/or industry experience in clinical development of cell therapies and/or therapies for autoimmune diseases is highly preferred. • Proven ability to interpret, discuss and present efficacy and safety data. • Strong knowledge of GCP/ICH, clinical trial design, clinical development processes, and regulatory requirements. • Strong ability to communicate and establish effective working relationship with investigators, collaborators, scientific advisors, CROs, and corporate partners.

Responsibilities

• Serve as the physician lead for CAR T-cell therapy clinical trials in autoimmune disease indications, in partnership with internal and external cross-functional teams. • Oversee medical monitoring of clinical trials, including engagement with site investigators and external medical monitors. • Partner with clinical operations, biometrics, regulatory, and commercial teams to ensure alignment on strategy and execution. • Lead design, execution, and interpretation of clinical trials across assigned program • Provide medical and scientific input into clinical development plans, study protocols, investigator brochures, and regulatory submissions. • Medical review, analysis, and interpretation of safety, efficacy, and PK and biomarker data. • Development of clinical trial documents including protocols, ICFs, clinical development plans, and publications. • Lead the development of clinical sections of regulatory documents including the IB, safety updates, clinical study reports, and responses to Health Authorities. • Actively engage with external investigators and researchers to identify, evaluate, and support investigator sponsored studies and drive research collaborations.