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The Manager, GxP Training will oversee quality training programs, manage training practices and SOPs, and ensure compliance with QMS. Responsibilities include delivering courses, reporting on training activities, and enhancing training through KPI evaluation and quality metrics preparation.

The Associate Director of Quality Assurance oversees Contract Manufacturing Organizations to support clinical manufacturing, develops internal QA processes, and manages Quality Assurance staff. Responsibilities include establishing Quality Metrics, ensuring compliance with cGMP, and maintaining effective oversight of clinical product quality, ensuring timely issue resolution and robust quality management strategies.

The Document Management Senior Specialist will manage documentation integrity, security, and compliance within a drug development environment. Responsibilities include overseeing document management systems, ensuring compliance with regulatory standards, supporting audits, training staff, and collaborating with cross-functional teams to enhance document management processes.

The Senior Director of Biostatistics will lead the Biostatistical group at Kyverna Therapeutics, providing strategic guidance and oversight for clinical studies. Responsibilities include statistical analysis execution, data collection support, management of clinical studies with CROs, regulatory interactions, and cross-functional collaboration to ensure successful trial execution and compliance with standards.

The Senior Data Scientist will collaborate across multi-disciplinary teams to build tools for data visualization and analysis, monitor CAR-T development processes, and facilitate QC to ensure product quality. Responsibilities include integrating high-dimensional data, creating dashboards, analyzing data from clinical trials, and driving understanding of mechanisms affecting patient outcomes.

The Senior Statistical Programmer will lead the development and implementation of programming standards for clinical study data analysis. Responsibilities include generating/validating datasets, approving CDISC-compliant datasets, managing timelines with CROs, and collaborating with teams on documentation and regulatory submissions.