Executive Director, Clinical Data Management

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