Executive Director, Clinical Data Management

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome, we are committed to transforming the future of treatment for autoimmune disease. Join us at the forefront of cell therapy innovation and help redefine what’s possible.

Title: Executive Director, Clinical Data Management

Reports to: SVP, Clinical and Development Operations

Location: Remote

Summary

The Executive Director, Clinical Data Management (CDM) is a senior leadership role responsible for defining and executing Kyverna’s global clinical data management strategy across its clinical development portfolio. This individual will provide strategic, operational, and organizational leadership to ensure the delivery of high-quality, regulatory-compliant, inspection-ready clinical data from study start-up through database lock, regulatory submission, and lifecycle management.

Operating in a fast-paced, growth-stage environment, the Executive Director will partner closely with Biostatistics, Statistical Programming, Clinical Operations, Regulatory, Clinical Development, Quality, and external partners, to establish scalable CDM strategies, governance models, processes, and systems that support Kyverna’s pipeline and global development activities.  This role will shape data standards, technologies, and operating models, while building and scaling a high-performing data management organization. The Executive Director will play a critical role in advancing Kyverna’s pipeline, ensuring data integrity, inspection readiness, and operational excellence.

Responsibilities

• Define, lead and execute the global Clinical Data Management strategy, aligned with Kyverna’s clinical, regulatory and corporate objectives
• Establish and evolve the CDM operating model, governance framework, resourcing strategy and organizational structure to support growth across programs and regions
• Serve as a key member of the Clin Development Operations leadership team, contributing to enterprise-level planning
• Lead the development and implementation of data standards, processes, and technologies, including CDISC and emerging industry best practices
• Drive innovation in data collection, integration, and analytics, including adoption of modern tools and automation
• Oversee standards governance, including management of deviations and continuous improvement initiatives
• Champion a data-driven culture, enabling real-time insights and decision-making across clinical programs
• Provide executive oversight of end-to-end CDM activities across all clinical studies, including: Study start-up planning, EDC/database and CRF design, Data validation, cleaning and reconciliation, Integration of external data (e.g. PK, biomarkers, etc..), Database locks and data transfers for analysis and submission
• Ensure delivery of high-quality, inspection-ready clinical data in line with program timelines and regulatory expectations
• Oversee development and review of key CDM deliverables, including, Data Management Plans (DMPs), edit check specifications, CRF design and completion guidelines and data review plans
• Provide strategic oversight of CDM systems and platforms to ensure scalability, compliance, efficiency, and long-term fit.
• Identify and drive opportunities for process optimization, automation, and innovation in data collection, integration, review and reporting.
• Evaluate emerging technologies, including AI-enabled solutions, to enhance data quality, efficiency, and transparency
• Ensure effective cross-functional data review and reconciliation across internal and external data sources
• Define and execute CDM vendor strategy, including selection, oversight, and performance management of CRO partners
• Provide senior-level oversight of vendor performances, including issue escalation, risk management, quality oversight, and continuous improvement
• Build strong, collaborative relationships with external vendors to ensure quality, efficiency, and scalability
• Drive accountability through KPIs, metrics, and governance frameworks
• Ensure compliance with global regulatory requirements, including 21 CFR Part 11, ICH-GCP, and CDISC standards
• Lead inspection readiness efforts for data management, including robust documentation, audit support and health authority interactions
• Ensure all CDM processes, systems, and documentation meet regulatory and quality standards
• Partner closely with Biostatistics, Statistical Programming, Clinical Operations, Clinical Development, Regulatory, and Quality