Sr. Medical Director, Clinical Development
Kyverna · Remote
Responsibilities:
- 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.
- 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.
- 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.
- 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.