Executive Director, Lifecycle Lead
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome, we are committed to transforming the future of treatment for autoimmune disease. Join us at the forefront of cell therapy innovation and help redefine what’s possible.
Title: Executive Director, Lifecycle Lead
Location: Remote (West Coast preferred)
Reporting to: Chief Medical & Development Officer
The Executive Director, Lifecycle Lead is responsible for leading one or more strategic development programs across the full product lifecycle—from early research and clinical development through process validation (PV/PPQ), commercial readiness, launch, and lifecycle management.
This role serves as the cross-functional leader accountable for defining and executing integrated asset strategies that maximize program value and align with Kyverna ’s portfolio and corporate objectives. The Lifecycle Lead partners closely with Research, Translational Sciences, Clinical Development, Regulatory Affairs, Technical Operations, Manufacturing & Supply, Quality, Medical Affairs, Commercial, and Business Development.
Responsibilities
- 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
Qualifications
- PhD or advanced degree and 10+ years in bio/pharma industry as a program/LCL lead.
- Proven experience in the field of biologics and autoimmune/oncology/hematology. A thorough knowledge of the pharmaceutical business model, of the value chain, especially in a Health Care environment.
- Experience of working with research, clinical & non-clinical development or commercial collaborations with alliance partners.
- Demonstrated Drug Development knowledge with understanding of the cross functional nature of the role including: Research, Translational Sciences, Clinical, Manufacturing, Commercial and Regulatory.
- Strong command of clinical data and able to interpret complex data packets
- Experience with NDA, BLA filings and regulatory submissions for different parts of a lifecycle both early and late.
- Exp