Job Description
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 recruiting for a Sr. Director, Clinical Scientist with deep expertise in Multiple Sclerosis (MS), and autoimmune disease to conduct and oversee clinical research studies in accordance with GCP, company policies, and regulatory requirements. This role will lead the scientific and operational execution of clinical programs focused on Multiple Sclerosis, supporting innovative cell therapy approaches designed to transform autoimmune treatment paradigms.
The Sr. Director will develop, lead, and maintain study protocols, informed consent forms, clinical study reports, and other key study documents through cross-functional collaboration with physicians, biostatisticians, clinical operations, translational sciences, regulatory, and data management teams to ensure successful execution of clinical trials. This position will also mentor and potentially manage Clinical Research Scientists and contribute to the development and optimization of clinical research processes and procedures.
Title: Sr. Director, Clinical Scientist
Location: Remote
Reports To:SVP, Clinical Development & Medical Affairs
Responsibilities
Clinical Development Strategy & Leadership
Serve as the senior clinical scientist for CAR T-cell therapy clinical trials in autoimmune disease indications, including Multiple Sclerosis (MS), partnering closely with internal and external cross-functional teams.
Strategically contribute to and lead clinical development plans and study execution activities for MS, 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.
Serve as a scientific subject matter expert in Multiple Sclerosis, 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.
Contribute to clinical development strategies incorporating biomarkers, MRI/imaging, translational endpoints, relapse assessment, and disability progression measures relevant to MS disease activity and progression.
Clinical Trial Execution & Oversight
Partner with Clinical Operations, Biometrics, Regulatory, Medical Affairs, and Commercial teams to ensure alignment on clinical strategy and execution.
Write and review scientific 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, with emphasis on leading MS clinical trial sites and investigators.
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 MS, neuroimmunology, autoimmune disease, and cell therapy communities.
Support development of scientific materials including slide decks, abstracts, posters, manuscripts, publications, congress presentations, and regulatory reports.
Prepare and review scientific 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
Lead, mentor, and develop high-performing Clinical Scientists and other Clinical Development staff.
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.
Provide strategic guidance and support to management in budget planning and resource prioritization.
Identify opportunities to improve clinical development processes, operational efficiency, and scientific quality.
Stay current with scientific and clinical advances in Multiple Sclerosis, neuroimmunology, autoimmune disease, and cell therapy.
Qualifications
Advanced scientific or clinical degree required (PhD, PharmD, MDor equivalent).
10+ years of progressive experience in clinical research, clinical development, and global late-stage clinical trial management within biotechnology or pharmaceutical industries.
Significant experience supporting or leading Multiple Sclerosis clinical development programs required.
Experience in cell therapy, gene therapy, immunology, autoimmune disease, or related therapeutic areas strongly preferred.
Deep understanding of neuroimmunology, autoimmune disease biology, MS clinical endpoints, biomarkers, imaging, and treatment landscape.
Demonstrated success developing and executing clinical strategies across multiple programs, including late-stage global clinical trials.
Strong knowledge of GCP, ICH guidelines, global regulatory frameworks, regulatory requirements, and clinical trial methodology.
Strong operational acumen with the ability to independently lead complex projects in fast-paced, highly matrixed organizations.
Experience interpreting complex clinical datasets, including safety, efficacy, biomarker, laboratory, and imaging data.
Experience with investigator-initiated and/or collaborative research trials preferred.
Prior management experience strongly 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.
Willingness and flexibility to travel up to 15% for congresses, investigator meetings, advisory boards, and clinical site visits as needed.
The national salary range for this position is $260K to $ 290 K USD annually. This salary range is an estimate of what we reasonably expect to pay for this position, and the actual salary may vary based on factors including experience, education, geographic location, internal equity, and market data. This position is also eligible for annual bonus, equity, benefits, and participation in the Company’s stock plan.
