The Role
Lead cross-functional asset strategy across the full product lifecycle for cell therapy programs, overseeing development, process validation, manufacturing readiness, regulatory filings, launch planning, and lifecycle expansion while aligning portfolio, commercial, and technical teams and managing partnerships, timelines, risks, and budgets.
Summary Generated by Built In
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.
- Experience of working in an international environment.
- Demonstrated ability to drive initiatives, solve issues, pre-empt problems and achieve objectives.
- Ability to multitask and promote objective deliverables in resource constraint environment.
- Experience in cross-functional drug development and clinical-stage program management.
- Understanding of the drivers of commercial success and the interplay between all customers, patients, physicians, pathologists/regulators payers etc.
- Ability to work effectively and manage stakeholders in a smooth & efficient way.
- Ability to drive delivery and advance complex global programs despite potentially adverse and changing conditions through effective governance and targeted executive escalation in a matrix organizational set up.
- Experience and ability to innovate and guide the team to think and deliver creatively in order to generate value.
- Demonstrated expert judgment with the ability to quickly identify, analyze, evaluate, escalate and/or resolve problems, which could negatively impact global program implementation and/or financial results.
- Excellent interpersonal and communication skills (verbal and written) with the ability to communicate and motivate with a persuasive, credible presentation style.
- Ability to resolve issues/ conflict in a constructive manner.
- Ability to develop bold ideas and take calculated risks.
- Strong tolerance for ambiguity, agility to adapt to change, confidence to speak-up and challenge appropriately.
The national salary range for this position is $270,000 to $305,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this position, and the actual salary may vary based on various factors, including without limitation individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data. This position is also eligible for bonus, benefits, and participation in Company’s stock plan.
Skills Required
- PhD or advanced degree and 10+ years in bio/pharma industry as a program/Lifecycle lead
- Proven experience in biologics and autoimmune, oncology, or hematology therapeutic areas
- Demonstrated drug development knowledge across Research, Translational Sciences, Clinical, Manufacturing, Commercial and Regulatory functions
- Experience with NDA, BLA filings and regulatory submissions across lifecycle stages
- Experience leading cross-functional drug development and clinical-stage program management
- Experience with manufacturing readiness including process characterization, tech transfer, PV/PPQ, comparability and supply chain readiness
- Experience working with research, clinical & non-clinical development or commercial collaborations with alliance partners
- Strong command of clinical data and ability to interpret complex data packets
- Experience working in an international environment
- Proven ability to drive initiatives, solve issues, pre-empt problems and achieve objectives in resource-constrained environments
- Excellent interpersonal and communication skills, persuasive credible presentation style
- Ability to manage stakeholders effectively in a matrix organization and escalate to executive governance when needed
- Demonstrated expert judgment to identify, analyze, evaluate, escalate and/or resolve issues affecting global program implementation or financial results
- Tolerance for ambiguity, agility to adapt to change, and ability to innovate and generate value
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The Company
What We Do
Kyverna is a cell therapy company engineering and developing a new class of curative living medicines for inflammatory and autoimmune diseases. Using its SmarTcell™ approach which includes synReg-T cell and synNotch CAR-T technology platforms, Kyverna reprograms T cells to target and selectively suppress or eliminate autoreactive immune cells. The company’s goal is to develop therapies that are selective, potent and durable to tame autoimmunity. We build interdisciplinary teams that bring a broad range of experiences and scientific expertise together to develop medicines that will free patients from the siege of autoimmune diseases and bring curiosity for exploring and creating the unknown. Our commitment to our employees is to foster an open, supportive, and inclusive environment where we create opportunities for individuals to learn and grow to their full potential at every level. synNotch is a trademark of Gilead/Kite.
