The Executive Director, Clinical Data Management leads the data management strategy, ensuring quality clinical data and compliance throughout the clinical development lifecycle.
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 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
Qualifications
- BS/MS in Life Sciences, Data Management, Computer Science, or related field (advanced degree preferred)
- 15+ years of progressive experience in clinical data management within biotech/pharma
- 8+ years of leadership experience building, scaling and leading high-performing CDM teams in a clinical-stage company
- Deep expertise in clinical data management, biometrics interfaces, clinical trial processes, and global regulatory expectations
- Strong knowledge of CDISC standards, 21 CFR Part 11, ICH-GCP, and global regulatory requirements
- Demonstrated experience defining and implementing data strategies, standards, and operating models across multiple studies and development stages
- Proven ability to lead cross-functionally and influence in highly matrixed environments
- Strong experience with CRO and vendor oversight, including managing complex vendor relationships
- Experience supporting regulatory submissions and health authority inspections
- Expertise in managing internal and external data sources (e.g., PK, ADA, biomarkers)
- Familiarity with data visualization and reporting tools (e.g., SAS, R, JReview, Spotfire, Tableau, Power BI)
- Strong leadership capabilities, including, strategic thinking and decision-making, organizational design and scaling, cross-functional influence and stakeholder management
- Excellent executive communication skills and presence, ability to engage effectively with senior leadership and external stakeholders
- Ability to thrive in a fast-paced, dynamic, and high-growth environment
- Experience in cell therapy, immunology, oncology or autoimmune disease programs strongly preferred
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