Medical Director/Sr. Medical Director, Clinical Development

🕒 May 18

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Kyverna Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2019

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 $85M Series B on 2022-01

Biotechnology • Pharmaceuticals • Science

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The company is pioneering CAR T-cell therapies, leveraging the transformational power of T cells to potentially provide sustained, treatment-free remission for autoimmune conditions. Kyverna's lead CAR T-cell therapy candidate, KYV-101, is advancing through clinical trials targeting various autoimmune diseases, including multiple sclerosis, myasthenia gravis, systemic sclerosis, and lupus nephritis. Their pipeline features innovative chimeric antigen receptor (CAR) T-cell therapies in both autologous and allogeneic formats aimed at B cell-driven autoimmune diseases.

📋 Description

• 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.

🎯 Requirements

• MD, DO, (or ex-US equivalent) or MD-PhD degree required. • 5+ years of clinical research experience with 3+ 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.

🏖️ Benefits

• annual salary in the range of $330,000 to $370,000 • bonus eligibility • participation in the Company’s stock plan