Kyverna - Therapeutics - Executive Director, Clinical Data Management

• 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 to support INDs, amendments, DSURs, BLAs and post-marketing commitments • Provide strategic input into clinical development plans, regulatory submissions, and data deliverables • Influence cross-functional stakeholders to ensure timely and high-quality data delivery • Build, lead and mentor a high-performing Clinical Data Management organization • Foster a culture of ownership, collaboration, accountability, and continuous learning aligned with company values. • Develop succession plans and capability roadmaps to support organizational growth and future pipeline needs