Kyverna Therapeutics
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Biotech
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.
Biotech
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.
Biotech
The Sr. Director of Marketing Promotions will lead promotional strategies, ensure compliance with regulations, and coordinate with various departments for successful product launches and lifecycle management.
