Kyverna Therapeutics

Director

• Develop and execute strategic account plans across health systems, IDNs, and treatment centers.
• Lead treatment center activation, onboarding, contracting, operational readiness, and site certification.
• Serve as the primary customer contact for CAR-T/cell therapy operations, logistics, and order management.
• Partner cross-functionally with Sales, Marketing, Medical Affairs, Market Access, Patient Services, Supply Chain, Manufacturing, Quality, Finance, Legal, and Commercial Operations to resolve issues and deliver key performance indicators.
• Support reimbursement strategies, and contracting initiatives.
• Drive expansion initiatives including satellite apheresis, outpatient treatment models, and multi-site frameworks.
• Analyze and monitor account performance, identify operational gaps, and implement continuous improvements.
• Represent customer insights, site performance and launch readiness in senior level meetings.
• Build executive relationships and lead strategic business reviews.

Senior Manager / Associate Director, Site Activation

Compliance

• Serve as the program manager for Kyverna’s enterprise compliance buildout and commercialization-readiness initiatives, coordinating cross-functional workstreams, owners, milestones, dependencies, deliverables, status reporting, and escalation of material blockers and risks.
• Develop and execute the enterprise compliance program strategy and roadmap, in partnership with and under the direction of the Chief Legal Officer, aligning program priorities with corporate objectives and commercial-readiness milestones.
• Lead the day-to-day operations of the Compliance function, establishing scalable governance, policies, systems, and processes that support sustainable organizational growth.
• Build and continuously enhance a risk-based enterprise compliance program, including healthcare compliance, aligned with the seven elements of an effective compliance program described in the HHS Office of Inspector General’s General Compliance Program Guidance.
• Serve as a strategic thought partner to the Chief Legal Officer and executive leadership team, influencing corporate strategy by proactively identifying compliance risks, regulatory trends, and opportunities that impact business decisions.
• Establish meaningful compliance metrics and reporting to evaluate program effectiveness, inform executive decision-making, and drive continuous improvement.
• Build the Compliance function over time, recommending organizational structure, talent, and capabilities to support the company's evolving business needs.
• Partner with Commercial, Medical Affairs, Clinical Development, Regulatory Affairs, Market Access, Human Resources, Finance, Privacy, Legal, and other business leaders to embed compliance into business operations. Work closely with Legal on privacy-related compliance processes and escalate privacy legal issues to the appropriate Legal lead.
• Provide practical guidance on healthcare compliance risks related to commercialization, including interactions with healthcare professionals, promotional activities, patient support programs, grants, speaker programs, and transparency requirements.
• Establish risk-based third-party compliance diligence, onboarding, monitoring, and recertification processes, and partner with Legal and business teams on compliance requirements and escalation procedures for higher-risk consultants, vendors, distributors, service providers, and strategic partners.
• Balance effective risk management with business enablement, supporting innovation while maintaining regulatory compliance.

Senior Director, Corporate Compliance

Manager

• Provide sponsor oversight of CMO QC labs in support of clinical manufacturing.
• Establish internal QC processes and maintain control strategy for investigational products.
• Support analytical control strategies for Kyverna’s clinical products including ownership of product specifications.
• Develop and maintain Kyverna’s stability program, including establishment of trend monitoring and statistical evaluation practices.
• Manage Validation/Qualification of Analytical methods as needed, to support multi-phase clinical trials.
• Provide subject matter expertise in the investigation of laboratory deviations, out of trend (OOT) and out of specification (OOS) events.
• Maintain Kyverna’s internal Quality Control data management and review process, and Certificate of Analysis (COA) generation.
• Support Manufacturing to develop and monitor key performance indicators and risk registry to ensure effective oversight of contract/external laboratories.
• Ensure QC issues are identified and managed through to resolution in a timely manner and deliverables are met as required.
• Work with functional leadership to design, implement and maintain Risk Based Quality Management strategies in support of Kyverna’s clinical programs.
• Support business development due diligence projects as needed to support analysis and assessment of internal/external laboratory capabilities.
• Other duties as assigned.

Senior Manager, Quality Control

• Manage and maintain processes, SOPs, and workflows for Deviations, Investigations, CAPA, Change Control, Quality Metrics, and other core QMS programs.
• Provide QA oversight of Information Technology systems supporting GxP processes.
• Lead or support the implementation, configuration, validation, and optimization of the electronic Quality Management System (eQMS), ensuring phase-appropriate design and scalability.
• Provide hands-on expertise in the day-to-day execution, review, and management of QMS records within the eQMS.
• Partner with internal stakeholders to define data governance, system configuration, user roles, and reporting requirements for quality systems.
• Ensure data integrity, traceability, and compliance of quality system data in accordance with regulatory expectations (e.g., ALCOA+ principles).
• Monitor overall QMS effectiveness, identify gaps or inefficiencies, and drive continuous improvement initiatives.
• Recommend updates to quality policies and procedures and implement process improvements aligned with organizational growth and regulatory readiness.
• Develop, compile, analyze, and present quality metrics and KPIs for routine quality management review.
• Perform trending and data analysis to identify risks, systemic issues, and opportunities for improvement.
• Create and deliver training programs related to QMS processes, data integrity, and eQMS functionality.
• Support inspection readiness and ensure adherence to cGMPs, regulatory mandates, and internal quality standards.
• Build and maintain strong cross-functional relationships and foster a culture of engagement, transparency, and quality ownership.
• Perform other duties as assigned.

Senior Manager, Quality Management System QMS

Project Manager

• Lead and maintain a global inspection readiness processes, timelines, and activities
• Collaborate closely with Kyverna QA, Clin Ops, Safety, Biometrics and other functions as needed to develop, align and drive inspection readiness remediation activities.
• Partner with Inspection readiness taskforce to define and operationalize inspection readiness frameworks, playbooks, and governance models
• Establish inspection simulation strategies, including mock audits and risk assessments
• Own end-to-end remediation planning and execution following audits/inspections
• Track and manage inspection findings, risks, and commitments through centralized dashboards
• Escalate risks proactively and implement mitigation strategies
• Build and manage integrated, cross-functional project plans with clear milestones and dependencies
• Drive accountability across stakeholders to meet critical timelines and deliverables
• Develop resource plans to support inspection readiness and remediation activities
• Partner with Quality to develop, refine, and implement SOPs, work instructions, and procedural documentation
• Ensure processes are aligned with GCP (Good Clinical Practice) and broader GxP requirements
• Influence without authority to drive execution across a matrixed organization

Inspection Readiness Project Manager – Contract

Sales

• Develop and execute the U.S. sales strategy supporting the commercialization of CAR-T for autoimmune diseases.
• Build and lead a best-in-class specialty sales organization capable of supporting current and future product launches.
• Establish commercial objectives, territory design, targeting strategies, and deployment models aligned with corporate goals.
• Drive revenue growth while ensuring compliance with all regulatory, legal, and company requirements.
• Partner with executive leadership to shape long-term commercial strategy and portfolio planning.
• Lead commercialization efforts across the CAR-T ecosystem, including treatment centers, referring physicians, infusion centers, and hospital systems.
• Develop strategies to optimize treatment center activation, patient identification, referral pathways, and patient access.
• Collaborate closely with Market Access, Cell Therapy Operations, Patient Services, and Medical Affairs to ensure seamless therapy adoption.
• Understand and address the complexities associated with cell collection, manufacturing, logistics, reimbursement, and site readiness.
• Monitor evolving CAR-T market dynamics, competitive intelligence, and emerging treatment paradigms.
• Establish and expand relationships with key neurology stakeholders, including academic centers, comprehensive neuroscience programs, and community neurologists.
• Drive customer engagement strategies supporting therapies for autoimmune neurological disorders, neurodegenerative diseases, and other complex neurological conditions.
• Develop disease-state education and value-based customer engagement approaches.
• Partner with Medical Affairs to ensure effective scientific exchange and customer education initiatives.
• Recruit, develop, and retain top-performing regional sales leaders and field sales professionals.
• Foster a high-performance culture focused on accountability, collaboration, innovation, and patient impact.
• Establish performance expectations, coaching programs, succession planning, and talent development initiatives.
• Lead ongoing training efforts focused on disease state expertise, clinical data, reimbursement, and customer engagement excellence.
• Partner closely with Market Access, Medical Affairs, Marketing, Commercial Operations, Patient Services, Legal, Compliance, and Finance.
• Ensure alignment between field execution and broader commercial strategies.
• Support forecasting, business planning, resource allocation, and launch readiness activities.
• Provide field insights to inform brand strategy, lifecycle planning, and evidence generation priorities.
• Establish and monitor KPIs related to sales performance, account engagement, treatment center activation, patient referrals, and market penetration.
• Utilize data analytics to optimize territory performance and resource deployment.
• Deliver regular business reviews and strategic recommendations to executive leadership.
• Identify opportunities to improve commercial effectiveness and customer experience.

Vice President, Sales

QA Engineer

• Service as primary Quality Assurance Point of contact for Contract Development and Manufacturing Organizations (CDMOs), providing strategic quality oversight and partnership management.
• Provide end-to-end oversight of Quality Operations across CDMOs (Plasmid, Viral Vector, and Cell Therapy Manufacturing and Testing), including Master Batch Record review and approval, product disposition, and continuous improvement of QA operational processes.
• Lead batch release activities for clinical and commercial products, ensuring compliance with applicable regulatory requirements and internal quality standards.
• Support Qualified Person (QP) certification activities by ensuring batches meet registered specifications, regulatory requirements, and current GMP expectations.
• Review and approve OOS, OOT, deviations, supplier change notifications, change controls, and related CAPAs, ensuring timely resolution and effective implementation.
• Monitor and report key quality and operational metrics related to product lifecycle and product journey milestones.
• Support Patient Operations in the on-boarding and continued performance of the apheresis collection centers and cell therapy labs according to program plans and strategy.
• Ensure adherence to cGMP regulations, ICH guidelines, and Kyverna SOPs
• Drive and support continuous improvement initiatives to enhance quality systems, operational efficiency, compliance, and inspection readiness.
• Support inspection readiness, other goals, and deliverables as required.

Senior Manager, QA Operations

Program Manager

• Provide Program Management expertise and leadership to advance Kyverna’s novel engineered T cell therapies.
• Manage one or more highly complex cross-functional development programs and/or high-profile partnerships.
• Effectively communicate with program team members, Senior Leadership Team, Functional Heads, and key stakeholders.
• Track and monitor key milestones and decision points to drive delivery of program objectives.
• Develop and maintain program management tools to support governance, integrated timelines, KPSs and risk tracking, as well as the communication of program KPIs, risks, and achievements.
• Lead or participate in one or more initiatives to build operational efficiency, company culture, and business processes.
• Translate program strategy into integrated cross-functional timelines, milestones, and deliverables
• Drive execution against critical path activities and ensure accountability for program timelines and deliverables.
• Lead or participate in one or more initiatives to build operational efficiency, company culture, and business processes.
• Manage the interfaces between functional areas and ensure effective handoff and communication between department functions to execute on important program milestones.
• Influence cross-functional stakeholders to align on priorities, resolve conflicts, and drive decision-making in a matrixed environment.
• Establish and support program governance forums, including team meetings and leadership updates; ensure decisions, risks, and actions are clearly documented and tracked.
• Proactively identify program risks, issues, and dependencies; develop mitigation strategies and escalate as appropriate.
• May be responsible for recruiting and supervising one or more Project Management Associates.

Director, Program Management

Vice President

• Evaluate, source and manage the network of contract manufacturers, cell collection centers, and contract development organizations.
• Evaluate, negotiate and implement major contracts related to manufacturing, procurement and logistics management for autologous and allogeneic CAR T therapies globally.
• Build and lead the manufacturing function and supply chain function, including relationship, technical management, contract negotiation and oversight of our external manufacturing and supply organizations.
• Build and lead the organization to provide and manage clinical supply, materials management, sourcing and strategic sourcing for the pipeline of cell therapies (both autologous and allogeneic) for Kyverna.
• Recruit, hire, and develop employees, and assess, recommend, and implement the structure and capabilities needed to grow the function in step with Kyverna’s strategic growth.
• Source and lead the evaluation of qualified organizations to provide critical services, materials, or products to Kyverna. Provide strategic input, including capital planning and capacity management, and information supporting the expansion of the Kyverna footprint globally. Assist teams in building the full business case with risks, opportunities and recommendations that support the growth of Kyverna.
• Lead the Supply and Ops planning for all products at Kyverna. Aggregate demand and ensure robust and agile supply strategies to meet demand.
• Participate as Member/Leader for Kyverna on JSCs with external members of the supply chain.
• Develop and lead the Business Operational reviews for manufacturing and supply of all Kyverna products. Assess and communicate the performance heatmap of the components of the entire supply chain. Escalate conditions of high risk and actively intervene to mitigate risks.
• Ensure network readiness for pivotal/registrational studies and launch/commercial supply activities.
• Develop and manage manufacturing and supply chain operational budget(s)
• Provide scientific and technical guidance and serve as SME for manufacturing processes and technology adoption.
• Establish and build the process for process monitoring and performance management of products produced in multiple supply points. Set the expectations for performance of this capability and manage the team to communicate and respond to signals indicating out-of-alignment conditions.
• Implement and operate the supply orchestrations systems for Kyverna to track, trace, and adjust the end-to-end patient journey, meeting scheduling requirements and optimizing patient experience.
• Support CMC and product development teams through collaboration on development of product history files, master files, site master plans and validation plans.
• Maintain current awareness of GMP/GTP and other regulations, guidance documents, advisory committees, industry standards and trends applicable to current and future cell therapy development operations and products.
• Provide key strategic Compliance best business practices to projects and cross-functional teams, including process development, manufacturing implementation, IMPD and IND preparation, and discussions with regulators.

Senior Vice President, Manufacturing and Supply

• Define and execute the company’s research and innovation strategy.
• Lead discovery, preclinical research, and early phase development.
• Shape the strategy for next-generation immune cell therapies and CAR-T innovation.
• Evaluate advances in CAR design, gene engineering, synthetic biology, immune tolerance, and related technologies.
• Build an innovation engine that generates future pipeline opportunities and platform extensions.
• Establish external collaborations with academic, biotech, and key opinion leaders.
• Monitor scientific and competitive landscapes to identify emerging opportunities.
• Build and advance a portfolio of next-generation therapeutic candidates.
• Evaluate next generation platform technologies to strengthen long-term competitive advantage.
• Prioritize discovery-stage investments and portfolio opportunities.
• Drive research focused on improving efficacy, safety, persistence, manufacturability, and patient experience.
• Assess novel immune cell engineering approaches and targeted immune reset strategies.
• Define platform evolution and pipeline expansion roadmaps.
• Partner with Business Development on external innovation and licensing opportunities.
• Ensure smooth transition from discovery to IND-enabling development.
• Support regulatory interactions and translational data packages.
• Collaborate with Clinical Development and Regulatory Affairs to enable clinical advancement.
• Establish governance, goals, and decision-making frameworks.
• Serve as a scientific advisor to cross functional teams.
• Represent Kyverna externally at conferences, advisory boards, and industry forums.
• Build relationships with key opinion leaders and external experts.
• Support business development, diligence, and strategic partnerships.
• Serve as a thought leader in immunology, autoimmune disease, and cell therapy innovation.

Vice President, Research - New Technologies

Operations

• Develop and execute channel strategies that balance customer experience, operational efficiency, compliance requirements, and gross-to-net (GTN) optimization.
• Serve as business owner for third-party logistics (3PL) partnerships and distribution operations supporting CAR T commercialization.
• Lead specialty pharmacy and distribution strategy development to support current and future portfolio needs.
• Partner with Market Access, Finance, Commercial, and Legal teams to evaluate channel design alternatives and their impact on GTN performance.
• Assess channel economics and recommend strategies that optimize reimbursement, contracting, distribution costs, and commercial profitability while maintaining customer satisfaction.
• Oversee state licensing strategy, renewals, compliance requirements, and regulatory readiness.
• Support government pricing activities through cross-functional coordination, process governance, and operational oversight.
• Lead distribution governance, service-level management, and operational performance reviews across external partners.
• Support launch planning, market expansion, and new product introductions through scalable channel infrastructure.
• Develop reporting, analytics, and performance metrics that provide visibility into channel effectiveness and operational health.
• Identify and mitigate operational, regulatory, and commercial risks across the distribution network.

Director, CAR T Channel Strategy – Operations

• 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

Executive Director, Lifecycle Lead – New Technologies

• Ensure adherence to report timelines and communicate issues to management as appropriate
• Develop and maintain an expert understanding of the latest safety regulations, technology, and safety profile of the assigned product(s) as well as understanding of the relevant strategic context (e.g., disease indication, safety profile of competitors, mechanism of action)
• Manage and support the relationship with safety vendors to ensure effectiveness, quality and compliance of all outsourced activities in collaboration with Director of PV operations.
• Lead oversight of quality and key performance indicators (case processing and aggregate reports) and present findings to Head of PV and relevant cross-functional stakeholders.
• Serve as resource for inspections and audits
• Ensure operational outputs support high-quality scientific safety assessment
• Lead signal detection and management activities, including literature search, data analyses, preparation of safety data for cross-functional safety team meetings, and drafting presentations and regulatory responses, in collaboration and consultation with the safety physician.
• Lead the drafting of safety sections of IB, aggregate reports (e.g. PADERs, PSURs, PBRERs, DSURs), and Risk Management Plans etc., in collaboration and consultation of the safety team and the cross-functional teams.
• Support and contribute to global regulatory submissions (e.g. drafting response to Health Authority requests, authoring and reviewing submission packages, etc.) with the safety team and the cross-functional experts.

Associate Director, Safety and Pharmacovigilance

• 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:
• Oversee the development and execution of key program deliverables including:

Vice President, Lifecycle Leader

• Lead the field market access organization, calling on payers and Treatment Centers.
• Drive appropriate access and coverage for Kyverna’s portfolio across payers and Cellular Therapy Treatment Centers.
• Serve as a player/coach and eventually lead a team responsible for developing and maintaining relationships with state Medicaid payers, MACs, national, and regional payers.
• Ensure coverage and reimbursement for Kyverna’s therapies.
• Build and execute account-specific business plans in alignment with broader market access and brand strategies.
• Deliver compelling value propositions and payer materials customized to each stakeholder’s needs.
• Track and report market trends, competitive intelligence, policy changes, and access barriers.
• Collaborate on the development of performance KPIs and metrics to evaluate access success and account performance.