Senior Medical Director, Clinical Development

🔥 11 hours ago

🇺🇸 United States – Remote

💵 $330k - $370k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

👻 Ghost score 8%

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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 senior physician for CAR T-cell therapy clinical trials in autoimmune disease indications • Lead clinical development plans and study execution activities for neuroimmunology, autoimmune disease, and cell therapy programs • Lead design, execution, interpretation, and reporting of clinical trials, including endpoints, biomarkers, imaging strategies, sample size, enrollment, timelines, and governance • Represent Clinical Development with leadership teams, KOLs, investigators, strategic partners, and external stakeholders • Oversee medical monitoring and engage with site investigators and external medical monitors • Provide medical and scientific input into development plans, protocols, investigator brochures, and regulatory submissions • Write and review protocols, IBs, ICFs, CSRs, safety updates, annual reports, BLA/CTA materials, and Health Authority responses • Review and interpret safety, efficacy, MRI/imaging, biomarker, laboratory, relapse, and disability progression data • Participate in investigator identification, selection, training, and site engagement • Collaborate with CROs and vendors to ensure study execution, enrollment performance, operational excellence, and inspection readiness • Ensure compliance with GCP, ICH guidelines, regulatory requirements, corporate policies, local laws, ethical approvals, and study oversight • Support patient safety monitoring, adverse event tracking, escalation, and protocol deviation follow-up • Contribute to scientific communication strategy and clinical data dissemination • Support slide decks, abstracts, posters, manuscripts, publications, congress presentations, and regulatory reports • Prepare and review responses to healthcare professional inquiries and scientific exchange requests • Participate in publication committees, advisory boards, scientific committees, and major congresses • Represent Clinical Development in advisory boards, regulatory meetings, investigator meetings, and scientific congresses • Support relationships with KOLs, investigators, academic collaborators, and strategic partners • Contribute to organizational design, talent development, onboarding, coaching, and capability building • Identify opportunities to improve clinical development processes, operational efficiency, and scientific quality • Stay current with advances in neuroimmunology, autoimmune disease, and cell therapy

🎯 Requirements

• MD, DO, or ex-US equivalent required • 5+ years of clinical research experience • At least 4 years of industry experience in clinical development, including clinical trial design and execution • Experience in late-stage clinical development highly preferred • Specialty training in neurology, rheumatology, nephrology and/or industry experience in clinical development of cell therapies and/or therapies for autoimmune diseases highly preferred • Ability to interpret, discuss, and present efficacy and safety data • Strong knowledge of GCP/ICH, clinical trial design, clinical development processes, and regulatory requirements • Ability to independently lead complex projects in a fast-paced, highly matrixed organization • Experience interpreting complex clinical datasets, including safety, efficacy, biomarker, laboratory, and imaging data • Experience with investigator-initiated and/or collaborative research trials preferred • Excellent verbal, written, presentation, and interpersonal communication skills • Ability to build relationships with internal stakeholders, investigators, KOLs, regulators, and scientific collaborators • Experience working in fast-paced and evolving biotech environments preferred

🏖️ Benefits

• Bonus eligibility • Health and welfare benefits • Participation in the Company’s stock plan • Up to 15% travel flexibility for congresses, investigator meetings, advisory boards, and clinical site visits