Sr. Medical Director, Clinical Development

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome, we are committed to transforming the future of treatment for autoimmune disease. Join us at the forefront of cell therapy innovation and help redefine what’s possible. 

Position Overview 

Kyverna is seeking a Sr. Medical Director, Clinical Development. This role will serve as a senior physician for CAR T-cell therapy clinical trials in autoimmune indications, providing medical oversight across study design, execution, and data interpretation. This person will partner cross-functionally to align on clinical strategy, lead oversight of medical monitoring activities, and directly engage with investigators and key thought leaders. In addition, this person will contribute to the development of clinical development plans, protocols, and regulatory submissions, and will also analyze safety, efficacy, PK, and biomarker data. In addition, this person will support external collaborations and investigator-sponsored research. 

Department:  Clinical Development 

Location: Remote eligible 

Reports To:  SVP, Clinical Development & Medical Affairs 

Willingness and flexibility to travel up to 15% for congresses, investigator meetings, advisory boards, and clinical site visits, as needed. 

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. 

Qualifications 

• MD, DO, (or ex-US equivalent) required.  

• 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. 

The salary range for this position is from $330,000 to 370,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position, and the actual salary may vary based on various factors, including without limitation individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data.  This position is also eligible for bonus, benefits, and participation in Company’s stock plan.