Vice President, Lifecycle Leader

Responsibilities

• Serve as the executive lifecycle lead for future indications and is accountable for the integrated asset strategy across clinical development, regulatory strategy, manufacturing readiness, and commercialization planning.
• Define and maintain the integrated development plan and lifecycle strategy, aligned with the Target Product Profile and long-term commercial value drivers.
• Drive strategic planning for key development milestones including Phase transitions, pivotal trial strategy, regulatory interactions, and launch readiness.
• Ensure program execution is aligned with corporate strategy, timelines, regulatory requirements, and budget targets.
• Lead and develop the Lifecycle Leaders organization, providing strategic oversight and mentorship to lifecycle leads across Kyverna’s development portfolio.
• Establish best-in-class lifecycle governance, decision frameworks, and cross-program coordination processes.
• Partner with the Executive Leadership Team to ensure portfolio prioritization and investment decisions align with corporate strategy and value creation.
• Standardize lifecycle strategy development, program governance, and cross-functional planning across programs.
• Serve as a primary strategic advisor to executive leadership on program strategy, portfolio risk, and lifecycle opportunities.
• Lead preparation and presentation of program updates, strategic options, and decision packages to governance committees and the Board.
• Ensure robust risk assessment, scenario planning, and mitigation strategies are in place across the program.
• Define go/no-go decision points and guide governance discussions around program investment and strategic direction.
• Represent Kyverna externally with key scientific, regulatory, and industry stakeholders.
• Support strategic partnerships, collaborations, and licensing discussions where appropriate.
• Engage with key opinion leaders and external experts to inform program strategy.
• Ensure coordinated execution across all functional areas including:
• • Clinical development
  • Regulatory strategy
  • CMC and manufacturing readiness
  • Medical affairs and scientific communications
  • Market access and commercial planning
   
  • Oversee the development and execution of key program deliverables including:
  • • Integrated development strategies and plans
    • Regulatory briefing documents
    • IND/BLA/NDA supporting materials
    • Clinical trial strategy
    • Scientific publications and congress presentations

Qualifications

• PhD, MD, PharmD, MBA or equivalent advanced degree preferred.
• 15+ years of experience in biotechnology or pharmaceutical drug development, including significant leadership experience in clinical-stage programs.
• Demonstrated success leading complex global development programs from early development through late-stage clinical trials and regulatory filings.
• Experience serving as a program or lifecycle leader for a major therapeutic asset is required.
• Experience in Neuroimmunology is strongly preferred.
• Strong expertise in autoimmune disease, immunology, cell therapy, biologics, or related therapeutic areas strongly preferred.
• Deep understanding of the end-to-end drug development value chain, including research, translational science, clinical development, regulatory, manufacturing, and commercialization.
• Experience with global regulatory interactions and major submissions (IND, BLA, NDA).
• Demonstrated leadership in cross-functional matrix organizations and enterprise governance structures.
• Ability to interpret complex clinical and scientific data and translate insights into strategic decisions.
• Experience leading cross-functional teams in high-growth biotechnology environments.
• Strategic, enterprise-level thinker capable of driving portfolio-level impact.
• Strong executive presence and ability to influence senior leadership and Board stakeholders.
• Proven ability to lead high-performing cross-functional teams in complex, fast-moving environments.
• Strong judgment and decision-making skills in the face of uncertainty and evolving scientific data.
• Excellent communication and stakeholder management skills.