Kyverna - Therapeutics - Sr. Medical Director, Clinical Development
Requirements
• 5+ years of clinical research experience with at least 4 years of industry experience in clinical development, including the design and execution of clinical trials. • 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. • 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 operational acumen with the 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. • Proven ability to support strong relationships with internal stakeholders, external investigators, KOLs, regulators, and scientific collaborators. • Experience working in fast-paced and evolving biotech environments preferred.
Responsibilities
• Clinical Development Strategy & Leadership • Serve as the senior physician for CAR T-cell therapy clinical trials in autoimmune disease indications, partnering closely with internal and external cross-functional teams. • Strategically contribute to and lead clinical development plans and study execution activities for neuroimmunology, autoimmune disease, and cell therapy programs. • Lead the design, execution, interpretation, and reporting of clinical trials across assigned programs, including study endpoints, biomarkers, imaging strategies, sample size considerations, patient enrollment approaches, timelines, and governance interactions. • Represent Clinical Development for assigned programs with cross-functional leadership teams, key opinion leaders (KOLs), investigators, strategic partners, and external stakeholders. • Oversee medical monitoring of clinical trials, including engagement with site investigators and external medical monitors. • Serve as a scientific subject matter expert in neuroimmunology, autoimmune disease biology, and cell therapy. • Maintain deep understanding of preclinical and clinical data relevant to the therapeutic platform, competitive landscape, and evolving MS treatment landscape. • Clinical Trial Execution & Oversight • Partner with Clinical Operations, Biometrics, Regulatory, Medical Affairs, and Commercial teams to ensure alignment on clinical strategy and execution. • Provide medical and scientific input into clinical development plans, study protocols, investigator brochures, and regulatory submissions. • Write and review relevant content of key clinical and regulatory documents including protocols, investigator brochures (IBs), informed consent forms (ICFs), clinical study reports (CSRs), safety updates, annual reports, BLA/CTA submission materials, and responses to Health Authorities. • Provide strategic oversight of informed consent language and patient risk communication. • Review and interpret safety, efficacy, MRI/imaging, biomarker, laboratory, relapse, and disability progression data throughout study conduct. • Participate in investigator identification, selection, training, and site engagement activities. • Collaborate with CROs and vendors to ensure high-quality study execution, enrollment performance, operational excellence, and inspection readiness. • Ensure study conduct aligns with GCP, ICH guidelines, regulatory requirements, corporate policies, and applicable local laws, including appropriate ethical review board approvals and study oversight. • Support the monitoring of patient safety during study conduct and appropriate tracking, escalation, and follow-up of adverse events and protocol deviations. • Scientific Communication & External Engagement • Contribute to scientific communication strategy and dissemination of clinical data across the neuroimmunology, autoimmune disease, and cell therapy communities. • Support development of materials including slide decks, abstracts, posters, manuscripts, publications, congress presentations, and regulatory reports. • Prepare and review responses to healthcare professional inquiries, scientific exchange requests, and external communications. • Participate in Publication Steering Committees (PSC), advisory boards, scientific committees, and major congresses relevant to neurology, immunology, autoimmune disease, and cell therapy. • Represent Clinical Development in high-impact external settings including advisory boards, regulatory meetings, investigator meetings, and scientific congresses, as appropriate. • Support strong relationships with KOLs, investigators, academic collaborators, and strategic partners. • Contribute to external scientific narrative and positioning through publications, presentations, and collaborations. • Leadership & Organizational Development • Contribute to organizational design, talent development, onboarding, coaching, and capability building to support future pipeline growth and complexity. • Foster a culture of collaboration, accountability, innovation, operational excellence, and scientific rigor. • Identify opportunities to improve clinical development processes, operational efficiency, and scientific quality. • Stay current with scientific and clinical advances in neuroimmunology, autoimmune disease, and cell therapy.
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