Search the 9 jobs at Kyverna Therapeutics

The Manager, Quality Systems will oversee quality systems activities including Deviations, Investigations, CAPAs, Change Controls, and Quality Metrics. This role requires close collaboration with Technical Operations, ensuring compliance with regulatory standards, and supporting continuous improvement in QMS programs.

The Senior Manager of Quality Assurance will oversee Contract Manufacturing Organizations (CMOs) to ensure compliance with Good Manufacturing Practices (GMP) and facilitate investigational product release for clinical trials. Responsibilities include batch record reviews, quality system approvals, on-site oversight, and managing relationships within the CMO network.

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 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 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.

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 Executive Director for Strategic Sourcing and Supply Chain at Kyverna Therapeutics will establish and manage sourcing and procurement operations, evaluate suppliers, negotiate contracts, and optimize supply chain functions for cell therapy products. Responsibilities include strategic input for capacity planning and partnerships, supporting business growth and assessing risks.

Assist in the implementation of data management tools, ensure timely data entry and verification, develop data dashboards, aggregate data from various sources, and perform statistical analyses. Collaborate with IT and manufacturing leads to establish validation methods for product lifecycle management.