Executive Director, Lifecycle Lead

🕒 il y a 1 mois

🇺🇸 États-Unis – Télétravail

💵 $270 000 - $305 000 / an

⏰ Temps Plein

🟠 Senior

👔 Directeur

👻 Score fantôme 11%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Kyverna Therapeutics

Site WebLinkedInTous les Emplois

51 - 200 employés

Fondée en 2019

🧬 Biotechnologie

💊 Pharmaceutique

🔬 Science

💰 €85 000 000 Series B en 2022-01

Biotechnology • Pharmaceuticals • Science

Kyverna Therapeutics est une entreprise biopharmaceutique en phase clinique, axée sur le patient, qui développe des thérapies cellulaires pour les patients souffrant de maladies auto-immunes. L'entreprise est pionnière dans les thérapies CAR T-cell, tirant parti du pouvoir transformationnel des cellules T pour potentiellement offrir une rémission durable sans traitement pour les maladies auto-immunes. Le principal candidat de thérapie CAR T-cell de Kyverna, KYV-101, progresse à travers des essais cliniques ciblant diverses maladies auto-immunes, y compris la sclérose en plaques, la myasthénie grave, la sclérodermie systémique et la néphrite lupique. Leur pipeline comprend des thérapies innovantes utilisant des récepteurs antigéniques chimériques (CAR) T-cell, tant dans les formats autologues qu'allogéniques, destinées aux maladies auto-immunes médiées par les cellules B.

Description

• 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

🎯 Exigences

• 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

🏖️ Avantages

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