[Remote] Sr. Director, Clinical Scientist
Note: The job is a remote job and is open to candidates in USA. Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. They are seeking a Sr. Director, Clinical Scientist to lead clinical research studies focused on Multiple Sclerosis and oversee the scientific and operational execution of clinical programs.ResponsibilitiesServe 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 teamsStrategically contribute to and lead clinical development plans and study execution activities for MS, neuroimmunology, autoimmune disease, and cell therapy programsLead 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 interactionsRepresent Clinical Development for assigned programs with cross-functional leadership teams, key opinion leaders (KOLs), investigators, strategic partners, and external stakeholdersServe as a scientific subject matter expert in Multiple Sclerosis, neuroimmunology, autoimmune disease biology, and cell therapyMaintain deep understanding of preclinical and clinical data relevant to the therapeutic platform, competitive landscape, and evolving MS treatment landscapeContribute to clinical development strategies incorporating biomarkers, MRI/imaging, translational endpoints, relapse assessment, and disability progression measures relevant to MS disease activity and progressionPartner with Clinical Operations, Biometrics, Regulatory, Medical Affairs, and Commercial teams to ensure alignment on clinical strategy and executionWrite 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 AuthoritiesProvide strategic oversight of informed consent language and patient risk communicationReview and interpret safety, efficacy, MRI/imaging, biomarker, laboratory, relapse, and disability progression data throughout study conductParticipate in investigator identification, selection, training, and site engagement activities, with emphasis on leading MS clinical trial sites and investigatorsCollaborate with CROs and vendors to ensure high-quality study execution, enrollment performance, operational excellence, and inspection readinessEnsure study conduct aligns with GCP, ICH guidelines, regulatory requirements, corporate policies, and applicable local laws, including appropriate ethical review board approvals and study oversightSupport the monitoring of patient safety during study conduct and appropriate tracking, escalation, and follow-up of adverse events and protocol deviationsContribute to scientific communication strategy and dissemination of clinical data across the MS, neuroimmunology, autoimmune disease, and cell therapy communitiesSupport development of scientific materials including slide decks, abstracts, posters, manuscripts, publications, congress presentations, and regulatory reportsPrepare and review scientific responses to healthcare professional inquiries, scientific exchange requests, and external communicationsParticipate in Publication Steering Committees (PSC), advisory boards, scientific committees, and major congresses relevant to neurology, immunology, autoimmune disease, and cell therapyRepresent Clinical Development in high-impact external settings including advisory boards, regulatory meetings, investigator meetings, and scientific congresses, as appropriateSupport strong relationships with KOLs, investigators, academic collaborators, and strategic partnersContribute to external scientific narrative and positioning through publications, presentations, and collaborationsLead, mentor, and develop high-performing Clinical Scientists and other Clinical Development staffContribute to organizational design, talent development, onboarding, coaching, and capability building to support future pipeline growth and complexityFoster a culture of collaboration, accountability, innovation, operational excellence, and scientific rigorProvide strategic guidance and support to management in budget planning and resource prioritizationIdentify opportunities to improve clinical development processes, operational efficiency, and scientific qualityStay current with scientific and clinical advances in Multiple Sclerosis, neuroimmunology, autoimmune disease, and cell therapySkillsAdvanced scientific or clinical degree required (PhD, PharmD, MD or equivalent)10+ years of progressive experience in clinical research, clinical development, and global late-stage clinical trial management within biotechnology or pharmaceutical industriesSignificant experience supporting or leading Multiple Sclerosis clinical development programs requiredDeep understanding of neuroimmunology, autoimmune disease biology, MS clinical endpoints, biomarkers, imaging, and treatment landscapeDemonstrated success developing and executing clinical strategies across multiple programs, including late-stage global clinical trialsStrong knowledge of GCP, ICH guidelines, global regulatory frameworks, regulatory requirements, and clinical trial methodologyStrong operational acumen with the ability to independently lead complex projects in fast-paced, highly matrixed organizationsExperience interpreting complex clinical datasets, including safety, efficacy, biomarker, laboratory, and imaging dataExcellent verbal, written, presentation, and interpersonal communication skillsProven ability to support strong relationships with internal stakeholders, external investigators, KOLs, regulators, and scientific collaboratorsWillingness and flexibility to travel up to 15% for congresses, investigator meetings, advisory boards, and clinical site visits as neededExperience in cell therapy, gene therapy, immunology, autoimmune disease, or related therapeutic areas strongly preferredExperience with investigator-initiated and/or collaborative research trials preferredPrior management experience strongly preferredExperience working in fast-paced and evolving biotech environments preferredBenefitsAnnual bonusEquityBenefitsParticipation in the Company’s stock planCompany OverviewKyverna Therapeutics is pioneering a new class of therapies and cures for serious autoimmune diseases. It was founded in 2018, and is headquartered in Berkeley, California, USA, with a workforce of 51-200 employees. Its website is http://kyvernatx.com.Company H1B SponsorshipKyverna Therapeutics has a track record of offering H1B sponsorships, with 1 in 2025, 1 in 2023, 1 in 2021. Please note that this does not guarantee sponsorship for this specific role.