Associate Director, TMF Lead

🕒 Julho 17

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Kyverna Therapeutics

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2019

🧬 Biotecnologia

💊 Farmacêutico

🔬 Ciência

💰 $85.000.000 Series B em 2022-01

Biotechnology • Pharmaceuticals • Science

Kyverna Therapeutics é uma empresa biofarmacêutica centrada no paciente e em estágio clínico, focada no desenvolvimento de terapias celulares para pacientes que sofrem de doenças autoimunes. A empresa está na vanguarda das terapias com células CAR T, aproveitando o poder transformador das células T para potencialmente proporcionar remissão sustentada e sem tratamento para condições autoimunes. O principal candidato a terapia com células CAR T da Kyverna, o KYV-101, está avançando em ensaios clínicos visando várias doenças autoimunes, incluindo esclerose múltipla, miastenia grave, esclerose sistêmica e nefrite lúpica. Seu pipeline apresenta terapias inovadoras com receptores de antígenos quiméricos (CAR) T-cells em formatos autólogos e alogênicos voltados para doenças autoimunes mediadas por células B.

Descrição

• Lead the end-to-end TMF strategy, including the transition from outsourced to in-house operations, ensuring control, scalability, and quality across all clinical studies. • Define and implement TMF governance, processes, and standards to ensure consistent document organization, classification, and filing in alignment with regulatory requirements and industry best practices. • Serve as the TMF subject matter expert, establishing clear expectations for document structure, naming conventions, indexing, and lifecycle management. • In partnership with Clinical Operations study lead, oversee TMF health across all studies, ensuring completeness, accuracy, and inspection readiness at all times through ongoing quality control and reconciliation. • Lead TMF activities across the study lifecycle, including study start-up, maintenance, and close-out, ensuring proper documentation, completeness reviews, and archival readiness. • Own and execute TMF migration efforts ensuring data integrity, completeness, and alignment with Kyverna standards. • Assess and evaluate TMF system providers by defining requirements, conducting vendor assessments, and leading cross-functional reviews to identify a compliant, scalable, and inspection-ready solution. • Partner closely with Clinical Operations, Clinical Development, Regulatory, Quality, IT and external partners to ensure seamless document flow and accountability. • Operate comfortably in both strategy and execution, including direct involvement in document review, filing quality, and issue resolution. • Establish TMF metrics and KPIs to proactively identify risks, drive continuous improvement, and ensure sustained inspection readiness. • Support regulatory inspections and audits as the TMF lead, ensuring readiness and effective responses to health authority inquiries.

🎯 Requisitos

• Bachelor’s degree in life sciences or related field; advanced degree preferred. • 10+ years of clinical research experience with a strong focus on TMF management. • Proven experience leading TMF operations, including both strategic oversight and hands-on execution. • Demonstrated experience transitioning TMF activities from outsourced to in-house models. • Strong expertise in Veeva Vault eTMF, including implementation, migration, and ongoing management. • Deep understanding of TMF structure, document taxonomy, and regulatory requirements (FDA, EMA, ICH-GCP). • Experience managing TMF across the full study lifecycle, including close-out and archival. • Experience leading TMF migration initiatives with a focus on quality and compliance. • Experience in biotech or cell and gene therapy. • Experience supporting regulatory inspections and audits. • Experience building or scaling TMF capabilities within a growing organization.

🏖️ Benefícios

• Bonus • Benefits • Participation in Company’s stock plan