Jobs at Kyverna Therapeutics

Leads enterprise technology strategy and IT organization growth for a clinical-stage biotech transitioning to commercial operations. Oversees enterprise applications, CRM and ERP integration, cybersecurity, infrastructure, cloud systems, data governance, GxP validation, IT operations, vendors, budgets, and regulatory readiness. Partners across commercial, medical, manufacturing, quality, regulatory, clinical, finance, HR, and legal functions to support product launch, field-force deployment, scalability, compliance, and operational excellence.

Contract pharmacovigilance Safety Writer/Scientist responsible for authoring safety assessments, signal evaluations, FDA Information Request responses, labeling content, advisory committee materials, risk-benefit analyses, RMPs, and clinical safety documents. The role also supports safety SOPs, inspection readiness, cross-functional review, and interpretation of adverse event data while ensuring regulatory compliance across FDA, EMA, PMDA, and other global requirements.

Leads clinical science strategy and execution for CAR T-cell therapy trials in autoimmune diseases. Oversees trial design, interpretation, clinical development plans, protocols, regulatory submissions, publications, and health authority interactions. Partners with cross-functional teams, investigators, key opinion leaders, and strategic partners while ensuring GCP and regulatory compliance. Represents clinical development externally, mentors clinical scientists, and supports organizational capability building.

Lead global regulatory strategy for Kyverna's cell therapy portfolio across development, approval, and commercialization. Drive labeling strategy, health authority engagements (FDA, EMA), regulatory submissions (INDs, BLAs/MAAs), and cross-functional alignment with Clinical, CMC, Commercial, Market Access, and Legal. Mentor and scale the regulatory team, manage external partners, and provide regulatory input for business development and portfolio decisions to enable launch readiness and lifecycle management.