Associate Director, Clinical Data Management

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Kyverna Therapeutics

WebsiteLinkedInAlle Stellen

51 - 200 Mitarbeiter

Gegründet 2019

🧬 Biotechnologie

💊 Pharmazie

🔬 Wissenschaft

💰 €85.000.000 Series B im 2022-01

Biotechnology • Pharmaceuticals • Science

Kyverna Therapeutics ist ein patientenorientiertes, biopharmazeutisches Unternehmen im klinischen Stadium, das sich auf die Entwicklung von Zelltherapien für Patienten mit Autoimmunerkrankungen konzentriert. Das Unternehmen ist Vorreiter bei CAR-T-Zelltherapien, indem es die transformativen Kräfte von T-Zellen nutzt, um möglicherweise eine anhaltende, behandlungsfreie Remission für Autoimmunerkrankungen zu bieten. Der führende CAR-T-Zelltherapie-Kandidat von Kyverna, KYV-101, befindet sich in klinischen Studien zur Behandlung verschiedener Autoimmunerkrankungen, darunter Multiple Sklerose, Myasthenia gravis, systemische Sklerose und Lupus-Nephritis. Ihre Pipeline umfasst innovative chimäre Antigenrezeptor (CAR)-T-Zelltherapien in sowohl autologen als auch allogenen Formaten, die auf B-Zell-getriebene Autoimmunerkrankungen abzielen.

Beschreibung

• 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

🎯 Anforderungen

• 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

🏖️ Vorteile

• bonus • benefits • participation in Company’s stock plan