Executive Director, Lifecycle Lead

🕒 3 dias atrás

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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 integrated asset strategy across the full lifecycle, including research, clinical development, PV/PPQ, commercialization, and lifecycle management • Drive strategic planning for emerging therapeutic platform technologies • Evaluate portfolio opportunities and recommend development pathways, platform investments, and lifecycle expansion strategies • Partner with Research, Translational Sciences, and Clinical Development to enable seamless transition from discovery through development • Provide strategic oversight of manufacturing readiness, including process characterization, tech transfer, PV/PPQ, comparability, and supply chain readiness • Ensure alignment across Clinical Development, Manufacturing/MSAT & Supply, Quality, Regulatory, and Commercial teams for late-stage development and launch planning • Guide commercialization strategy, including launch readiness, market access, product differentiation, and lifecycle expansion • Partner with Project Management lead to develop and manage program timelines, action items, issues/risks and budget • Support governance decisions on manufacturing strategy, CDMO partnerships, network design, capacity planning, and commercial supply • Partner with Research, Translational Sciences, and Technical Development to advance next-generation therapeutic modalities and platform technologies • Ensure development strategies reflect platform-specific regulatory, manufacturing, clinical, and commercial considerations • Drive integrated multi-platform planning with focus on portfolio value and risk mitigation • Lead cross-functional planning for INDs, BLAs, label expansions, post-marketing commitments, and global lifecycle management • Work with third party technology and/or development partners to advance programs and operational plans

🎯 Requisitos

• PhD or advanced degree • 10+ years in the bio/pharma industry as a program/LCL lead • Proven experience in biologics and autoimmune/oncology/hematology • Thorough knowledge of the pharmaceutical business model and value chain, especially in a Health Care environment • Experience working with research, clinical and non-clinical development, or commercial collaborations with alliance partners • Demonstrated drug development knowledge across Research, Translational Sciences, Clinical, Manufacturing, Commercial, and Regulatory functions • Strong command of clinical data and ability to interpret complex data packets • Experience with NDA, BLA filings, and regulatory submissions across different lifecycle stages • Experience working in an international environment • Experience in cross-functional drug development and clinical-stage program management • Understanding of commercial success drivers and stakeholder interplay across customers, patients, physicians, pathologists, regulators, and payers • Ability to drive initiatives, solve issues, pre-empt problems, and achieve objectives • Ability to multitask and promote objective deliverables in a resource-constrained environment • Ability to work effectively and manage stakeholders smoothly and efficiently • Ability to drive delivery and advance complex global programs through effective governance and targeted executive escalation in a matrix organization • Experience and ability to innovate and guide teams to think and deliver creatively • Demonstrated expert judgment to identify, analyze, evaluate, escalate, and/or resolve problems affecting global program implementation or financial results • Excellent verbal and written interpersonal and communication skills, with persuasive and credible presentation ability • Ability to resolve issues and conflicts constructively • Ability to develop bold ideas and take calculated risks • Strong tolerance for ambiguity, agility to adapt to change, confidence to speak up, and ability to challenge appropriately

🏖️ Benefícios

• Eligible for bonus • Benefits • Participation in Company’s stock plan