Kyverna Therapeutics

Medical Director

• 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

Senior Medical Director, Clinical Development

Content Writer

• Author comprehensive safety assessment reports, including signal evaluations
• Prepare and draft responses to FDA Information Requests
• Prepare and draft core safety reference information or justification for safety sections of labels
• Prepare and draft slides for safety-related presentations for internal and external meetings, including FDA advisory committee meetings
• Collaborate with cross-functional teams to ensure consistency and completeness of safety narratives and analyses
• Contribute to risk-benefit analyses, RMP writing, and safety sections for clinical and safety documents, including IBs and CSRs
• Assist in drafting, editing, formatting, and maintaining safety-related SOPs and work instructions
• Ensure SOPs align with current regulatory requirements and internal quality standards
• Support inspection readiness activities

Safety Writer – Contract

• Serve as the senior clinical scientist for CAR T-cell therapy clinical trials in autoimmune disease indications, in partnership with internal and external cross-functional teams
• 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 the assigned program
• Provide scientific input into clinical development plans, study protocols, investigator brochures, and regulatory submissions
• Participate in developing clinical trial documents, including protocols, ICFs, clinical development plans, and publications
• Lead development of clinical sections of regulatory documents, including the IB, safety updates, clinical study reports, and responses to Health Authorities in collaboration with the study physician
• Represent Clinical Development for the assigned program with cross-functional leaders, key opinion leaders, strategic partners, and external stakeholders
• Represent Clinical Development in advisory boards, regulatory meetings, and major congresses, as appropriate
• Contribute to external scientific narrative and positioning through publications, presentations, and collaborations
• Ensure compliance with GCP, corporate policies, and applicable local regulations
• Lead, mentor, and develop clinical scientists and other staff
• Foster a culture of innovation, accountability, and scientific rigor
• Contribute to Clinical Development organizational design and capability building to support future pipeline growth and complexity

Senior Medical Director, Clinical Development

Safety Writer – Contract

Senior Director, Clinical Science