Executive Director, Clinical Data Management

📋 Description

• Define, lead, and implement the global Clinical Data Management strategy that aligns with Kyverna’s clinical, regulatory, and corporate goals.

• Establish and refine the CDM operating model, governance framework, resourcing strategy, and organizational structure to facilitate growth across various programs and regions.

• Act as a vital member of the Clinical Development Operations leadership team, contributing to enterprise-level planning.

• Lead the creation and execution of data standards, processes, and technologies, incorporating CDISC and emerging best practices from the industry.

• Foster innovation in data collection, integration, and analytics, including the adoption of contemporary tools and automation.

• Oversee standards governance, managing deviations and continuous improvement initiatives.

• Promote a data-driven culture that enables real-time insights and decision-making throughout clinical programs.

• Provide executive oversight of all CDM activities across clinical studies, encompassing: 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 the delivery of high-quality, inspection-ready clinical data that aligns with program timelines and regulatory expectations.

• Supervise the development and review of essential CDM deliverables, including Data Management Plans (DMPs), edit check specifications, CRF design, completion guidelines, and data review plans.

• Provide strategic oversight of CDM systems and platforms to guarantee scalability, compliance, efficiency, and long-term suitability.

• Identify and pursue opportunities for process optimization, automation, and innovation within data collection, integration, review, and reporting.

• Assess emerging technologies, including AI-enabled solutions, to improve data quality, efficiency, and transparency.

• Ensure effective cross-functional data review and reconciliation across both internal and external data sources.

• Define and execute the CDM vendor strategy, including selection, oversight, and performance management of CRO partners.

• Provide senior-level oversight of vendor performance, including issue escalation, risk management, quality oversight, and continuous improvement.

• Cultivate 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 initiatives for data management, emphasizing robust documentation, audit support, and interactions with health authorities.

• Ensure all CDM processes, systems, and documentation adhere to regulatory and quality standards.

• Work closely with Biostatistics, Statistical Programming, Clinical Operations, Clinical Development, Regulatory, and Quality teams 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 guarantee 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 in line with company values.

• Develop succession plans and capability roadmaps to support organizational growth and future pipeline needs.

⛳️ Requirements

• BS/MS in Life Sciences, Data Management, Computer Science, or a related field (advanced degree preferred).

• Over 15 years of progressive experience in clinical data management within the biotech/pharma sector.

• More than 8 years of leadership experience in building, scaling, and managing high-performing CDM teams in a clinical-stage company.

• Extensive 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.

• Proven experience in defining and implementing data strategies, standards, and operating models across various studies and development phases.

• Demonstrated ability to lead cross-functionally and influence within highly matrixed environments.

• Significant experience with CRO and vendor oversight, including managing complex vendor relationships.

• Experience supporting regulatory submissions and health authority inspections.

• Expertise in managing both 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 skills, including strategic thinking, decision-making, organizational design and scaling, and stakeholder management.

• Excellent executive communication skills and presence, with the ability to engage effectively with senior leadership and external stakeholders.

• Ability to thrive in a fast-paced, dynamic, high-growth environment.

• Experience in cell therapy, immunology, oncology, or autoimmune disease programs is strongly preferred.

🏝️ Benefits

• This position is also eligible for bonus.

• Benefits.

• Participation in the Company’s stock plan.