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Senior Medical Director, Clinical Development
Kyverna Therapeutics. Serve as senior physician for CAR T-cell therapy clinical trials in autoimmune disease indications .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial design and execution, particularly in neuroimmunology and autoimmune diseases, while ensuring compliance with GCP and ICH guidelines. Capable of leading complex projects and fostering relationships with key opinion leaders and stakeholders in a fast-paced biotech environment.
Highest-signal resume keywords
MD, DO, Or Ex-US EquivalentClinical Trial Design And ExecutionGCP/ICH ComplianceClinical Research ExperienceNeuroimmunology And Autoimmune Disease Expertise
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Development PlansData InterpretationSafety And Efficacy AnalysisRegulatory SubmissionsBiomarker AnalysisMedical MonitoringStudy ExecutionProtocol DevelopmentEnrollment PerformanceOperational Excellence
Soft Skills
Excellent Communication SkillsRelationship BuildingLeadershipInterpersonal SkillsCoaching And Talent Development
Industry Keywords
Cell TherapyAutoimmune DiseaseNeuroimmunologyClinical ResearchBiotech EnvironmentInvestigator-Initiated TrialsAdverse Event TrackingScientific CommunicationClinical Data DisseminationFast-Paced Organization
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- 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
Requirements
What you’ll need- MD, DO, or ex-US equivalent required
- 5+ years of clinical research experience
- At least 4 years of industry experience in clinical development, including clinical trial design and execution
- 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
- Ability to interpret, discuss, and present efficacy and safety data
- Strong knowledge of GCP/ICH, clinical trial design, clinical development processes, and regulatory requirements
- 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
- Ability to build relationships with internal stakeholders, investigators, KOLs, regulators, and scientific collaborators
- Experience working in fast-paced and evolving biotech environments preferred
Benefits
Comp & perks- Bonus eligibility
- Health and welfare benefits
- Participation in the Company’s stock plan
- Up to 15% travel flexibility for congresses, investigator meetings, advisory boards, and clinical site visits