Jobs at Kyverna Therapeutics

Lead strategy and execution of an in-house Trial Master File (TMF) function, transitioning from outsourced to internal operations. Ensure TMFs are inspection-ready across study lifecycle, manage Veeva Vault eTMF implementations and migrations, define governance and KPIs, partner cross-functionally, and support regulatory inspections and audits.

Lead QC oversight for clinical cell therapy manufacturing and external CMO labs. Own product specifications, stability programs, method validation/transfer, investigation of OOS/OOT events, COA generation, KPI monitoring, and risk-based quality management to support multi-phase clinical programs.

The Senior Clinical Research Scientist will design, execute, and analyze clinical studies, ensuring compliance with GCP and regulatory requirements, and collaborate across multiple departments.

Lead technology strategy and operations for a commercializing biotech: define multi-year roadmap, deploy commercial and enterprise systems, ensure cybersecurity and GxP validation, manage infrastructure, data governance, vendors, and IT teams to support commercialization, regulatory readiness, and operational excellence.

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.

Lead discovery and early development strategy for next-generation immune cell therapies. Oversee multidisciplinary teams, evaluate and advance in vivo CAR-T and cellular engineering technologies, build external collaborations, prioritize discovery investments, and partner with clinical, regulatory, and business teams to progress candidates from discovery through IND-enabling development.

Lead development and execution of CAR T channel strategy and operations, overseeing 3PL, specialty pharmacy, distribution, state licensing, government pricing support, GTN optimization, partner governance, launch readiness, reporting, and cross-functional coordination to ensure scalable, compliant commercialization.

Senior leader accountable for integrated development and commercialization strategy of CAR-T programs. Leads lifecycle governance, cross-functional coordination, portfolio prioritization, regulatory and manufacturing readiness, risk assessment, and executive-level decision-making to advance programs from development through regulatory filings and launch.

Lead cross-functional program management for engineered T cell therapy development. Translate strategy into integrated plans, track milestones and risks, drive execution and governance, align stakeholders, and build operational processes. May recruit and supervise junior PM staff.

Lead U.S. commercial sales and go-to-market strategy for CAR-T therapies. Build and scale a specialty sales organization, drive launches and market penetration, manage field teams, collaborate cross-functionally on access and site readiness, and use analytics to monitor KPIs and optimize performance.