Executive Director, Regulatory Affairs

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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

• Provide strategic and operational regulatory leadership across Kyverna's cell therapy portfolio, with a focus on commercial readiness, labeling strategy, and health authority engagement. • Lead global regulatory strategy for Kyverna's development programs, aligning clinical, CMC, and commercial objectives from early development through post-approval lifecycle management. • Provide regulatory input to program governance, asset prioritization, and portfolio decisions, including scenario planning and risk mitigation. • Anticipate and address regulatory challenges related to cell therapy development, manufacturing, comparability, and long-term follow-up. • Serve as the primary senior regulatory interface with FDA, EMA, and other global health authorities. • Lead and/or support key regulatory meetings, including INTERACT, pre-IND, End-of-Phase, pre-BLA/MAA, Advisory Committees, and post-marketing commitments. • Drive regulatory negotiation strategy, including benefit-risk, endpoints, comparability, and post-approval requirements. • Own and drive labeling strategy from early development through approval, ensuring labels support commercial differentiation, patient access, and lifecycle value. • Lead development of Target Product Profiles (TPPs) and ensure alignment across Clinical, Regulatory, Commercial, and Market Access. • Partner with Commercial, Medical Affairs, and Market Access to ensure regulatory decisions support launch readiness, promotional strategy, and payer engagement. • Lead label negotiations with health authorities, balancing scientific evidence, regulatory expectations, and commercial objectives. • Oversee and contribute to the preparation, review, and submission of INDs, CTAs, BLAs/MAAs, briefing packages, orphan drug applications, and other regulatory filings. • Ensure submissions are high-quality, compliant, and strategically positioned. • Maintain oversight of submission timelines, dependencies, and risk management, providing clear communication to senior leadership. • Act as a strategic partner to Clinical Development, CMC, Research, Commercial, Legal, BD, and Alliance Management teams. • Provide regulatory due diligence and strategic input for business development, in-licensing, out-licensing, and partnership opportunities. • Oversee regulatory activities performed by CROs, consultants, and partners, ensuring quality and strategic alignment. • Lead, mentor, and scale a high-performing regulatory team, fostering accountability, development, and a culture of collaboration. • Establish and maintain regulatory policies, procedures, and infrastructure to support a growing, late-stage organization.

🎯 Anforderungen

• Bachelor's degree in a scientific discipline required; advanced degree preferred. • 15+ years of progressive regulatory affairs experience in pharmaceutical or biotechnology, with significant advanced therapy experience. • Cell and/or gene therapy experience preferred; autoimmune disease experience highly preferred. • Demonstrated success leading global regulatory strategies through late-stage development and/or approvals, ideally including BLA/MAA experience. • Proven experience with labeling strategy development and negotiation, with strong understanding of commercialization impacts. • Deep knowledge of FDA regulations, ICH guidelines, and global regulatory frameworks; EMA and ex-US experience preferred. • Track record of effective engagement with FDA OTP and/or divisions overseeing autoimmune or immune-mediated diseases. • Strong executive communication skills with the ability to influence senior leadership and Board-facing audiences. • Demonstrated ability to lead and scale teams in a fast-paced, high-growth environment. Prior supervisory experience preferred. • Strategic mindset with the ability to balance scientific rigor, regulatory compliance, and commercial impact.

🏖️ Vorteile

• eligible for bonus • benefits • participation in the company's stock plan