Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases.
Lead the scientific and operational execution of clinical programs focused on Multiple Sclerosis.
Develop, lead, and maintain study protocols, informed consent forms, clinical study reports, and other key study documents.
Mentor and potentially manage Clinical Research Scientists.
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.
Review and interpret safety, efficacy, MRI/imaging, biomarker, laboratory, relapse, and disability progression data throughout study conduct.
Collaborate with CROs and vendors to ensure high-quality study execution, enrollment performance, operational excellence, and inspection readiness.
Support the monitoring of patient safety during study conduct and appropriate tracking, escalation, and follow-up of adverse events and protocol deviations.
Represent Clinical Development in high-impact external settings including advisory boards, regulatory meetings, investigator meetings, and scientific congresses.
Requirements
Advanced 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 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.
Tech Stack
Google Cloud Platform
Benefits
annual bonus
equity
benefits
participation in the Company’s stock plan
Senior Director, Clinical Scientist at Kyverna Therapeutics | JobVerse