Kyverna Therapeutics→
Associate Director, Clinical Data Management at Kyverna… · Remote
Skills
Job Description
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: Associate Director, Clinical Data Management Reports to: Executive Director, Clinical Data Management Location: Remote
Summary
The AD, Clinical Data Management (CDM) is responsible for leading and overseeing clinical data management activities across assigned clinical studies to ensure the delivery of high-quality, regulatory-compliant, and inspection-ready clinical data. This individual will provide strategic and operational leadership for end-to-end data management activities from study start-up through database lock and submission support.
Operating in a fast-paced, growth-stage environment, the Associate Director will partner closely with Clinical Operations, Biostatistics, Statistical Programming, Clinical Development, Regulatory, Quality, and external vendors to drive efficient and scalable data management processes, standards, and technologies. This role will contribute to the evolution of Kyverna’s CDM infrastructure and operating model while supporting multiple studies across the clinical development portfolio.
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: Associate Director, Clinical Data Management Reports to: Executive Director, Clinical Data Management Location: Remote
Summary
The AD, Clinical Data Management (CDM) is responsible for leading and overseeing clinical data management activities across assigned clinical studies to ensure the delivery of high-quality, regulatory-compliant, and inspection-ready clinical data. This individual will provide strategic and operational leadership for end-to-end data management activities from study start-up through database lock and submission support.
Operating in a fast-paced, growth-stage environment, the Associate Director will partner closely with Clinical Operations, Biostatistics, Statistical Programming, Clinical Development, Regulatory, Quality, and external vendors to drive efficient and scalable data management processes, standards, and technologies. This role will contribute to the evolution of Kyverna’s CDM infrastructure and operating model while supporting multiple studies across the clinical development portfolio.
Responsibilities
Lead end-to-end Clinical Data Management activities for assigned clinical studies from study start-up through database lock and archival
Provide operational leadership for study timelines, deliverables, risks, and quality across internal teams and external vendors
Oversee key CDM activities including: Database build and validation, eCRF design and review, Edit check specifications, Data review and cleaning, External data reconciliation (e.g., PK, biomarkers, central labs, imaging),, Database lock activities, Data transfers for statistical analysis and regulatory submissions
Review and approve key CDM documentation including: Data Management Plans (DMPs), Data Review Plans, CRF Completion Guidelines, Vendor data transfer specifications, Database validation documentation
Ensure clinical data are accurate, complete, consistent, and inspection-ready in compliance with timelines and regulatory requirements
Partner cross-functionally with Clinical Operations, Biostatistics, Statistical Programming, Clinical Development, Regulatory, and Quality to support study execution and submission readiness
Contribute to the development and implementation of CDM standards, SOPs, processes, and best practices
Support standardization initiatives aligned with CDISC standards and evolving industry practices
Drive proactive risk identification, issue escalation, and resolution across study teams and vendors
Lead and manage CRO/vendor relationships for data management activities, including oversight of quality, timelines, budgets, and performance metrics
Support governance meetings and vendor performance reviews to ensure accountability and continuous improvement
Collaborate with cross-functional stakeholders to support data review, reconciliation, and clinical data integrity
Support inspection readiness activities, audits, and health authority inspections related to clinical data management
Support process optimization, automation, and innovation to improve operational efficiency and data quality
Contribute to building a collaborative, high-performing CDM function aligned with company values
Qualifications
BS/MS in Life Sciences, Computer Science, Data Management, or related discipline
10+ years of progressive experience in Clinical Data Management within biotech or pharmaceutical industries
3+ years of experience overseeing clinical studies and managing CDM vendors
Strong understanding of clinical trial processes, clinical data flows, and global regulatory requirements
Working knowledge of CDISC standards, 21 CFR Part 11, and ICH-GCP guidelines
Experience managing end-to-end data management activities across Phase 1–3 clinical studies
Demonstrated experience overseeing CROs and external vendors in a matrixed environment
Experience supporting regulatory submissions and inspection readiness activities
Familiarity with EDC systems and data review/reconciliation tools
Experience managing external data sources including PK, ADA, biomarkers, imaging, and central laboratory data
Strong organizational, problem-solving, and project management skills
Excellent communication and cross-functional collaboration skills
Ability to effectively prioritize and manage multiple studies in a fast-paced environment
Experience in cell therapy or autoimmune disease programs strongly preferred
The national salary range for this position is $175K to $195K USD annually. This salary range is an estimate of what we reasonably expect to pay for this position, and the actual salary may vary based on various factors, including without limitation individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data. This position is also eligible for bonus, benefits, and participation in Company’s stock plan.