Kyverna Therapeutics

Director

• 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

Vice President

• 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.

Senior Director, Field Market Access

Content Writer

• Drive operational excellence and consistency across Medical Writing deliverables in support of inspection readiness and regulatory submissions
• Responsible for document coordination and control, SOP authorship support, template maintenance, and process aid development, version management, and cross-functional alignment
• Oversee document review coordination, including preparing and aligning reviewer rosters
• Coordinate QC activities for clinical and regulatory documents, including working with external vendors to ensure timelines and deliverables are met
• Ensure QC-reviewed and final documents are properly archived and traceable in Veeva
• Develop and maintain document trackers for version history, ownership, and approvals to support audit readiness
• Support documentation and tracking activities for audit and inspection readiness, including CAPA follow-up

Medical Writing Operations Manager

Clinical Research

• Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases.
• Lead the scientific and operational execution of clinical programs focused on Multiple Sclerosis.
• Develop, lead, and maintain study protocols, informed consent forms, clinical study reports, and other key study documents.
• Mentor and potentially manage Clinical Research Scientists.
• Partner with Clinical Operations, Biometrics, Regulatory, Medical Affairs, and Commercial teams to ensure alignment on clinical strategy and execution.
• Write and review scientific content of key clinical and regulatory documents.
• Review and interpret safety, efficacy, MRI/imaging, biomarker, laboratory, relapse, and disability progression data throughout study conduct.
• Collaborate with CROs and vendors to ensure high-quality study execution, enrollment performance, operational excellence, and inspection readiness.
• Support the monitoring of patient safety during study conduct and appropriate tracking, escalation, and follow-up of adverse events and protocol deviations.
• Represent Clinical Development in high-impact external settings including advisory boards, regulatory meetings, investigator meetings, and scientific congresses.

Senior Director, Clinical Scientist

Medical Director

• Serve as the physician lead for CAR T-cell therapy clinical trials in autoimmune disease indications, in partnership with internal and external cross-functional teams.
• Oversee medical monitoring of clinical trials, including engagement with site investigators and external medical monitors.
• Partner with clinical operations, biometrics, regulatory, and commercial teams to ensure alignment on strategy and execution.
• Lead design, execution, and interpretation of clinical trials across assigned program.
• Provide medical and scientific input into clinical development plans, study protocols, investigator brochures, and regulatory submissions.
• Medical review, analysis, and interpretation of safety, efficacy, and PK and biomarker data.
• Development of clinical trial documents including protocols, ICFs, clinical development plans, and publications.
• Lead the development of clinical sections of regulatory documents including the IB, safety updates, clinical study reports, and responses to Health Authorities.
• Actively engage with external investigators and researchers to identify, evaluate, and support investigator sponsored studies and drive research collaborations.

Medical Director/Sr. Medical Director, Clinical Development

• Develop, implement, and manage Kyverna’s Quality Management System.
• In close collaboration with Technical Operations and Clinical Functions, define the requirements for a late phase and commercial lifecycle stage-appropriate quality system.
• Drive the maturation and continuous improvement of the QMS to support clinical development through commercialization.
• Represent Quality and provide Quality leadership on cross-functional project and program teams, as required.
• Ensure compliance with all applicable regulations, industry best practices, and standards related to Kyverna products. Adapt the QMS per region-specific requirements as required.
• Serve as the Quality business process owner (BPO) and provide oversight for Change Management, Deviation/CAPA Management, Document Lifecycle Management, Records Management, Training Program, Quality Risk Management, Computer Systems Quality Assurance, Quality Management Review, and Quality Governance Boards.
• Lead Quality Management Review and Quality Governance Board (such as Material Review Boards, Specification Review Boards, Change Control Review Boards, etc.) meetings and monitor the state of control of Kyverna’s QMS.
• Set and/or facilitate establishment of key performance indicators and metrics. Perform trend analysis and assess QMS processes for potential gaps to ensure compliance and to monitor the health of the QMS. Ensure proper communication and escalation to peers, senior, and executive management as required.
• Assist in the development and deployment of quality systems in accordance with ICH Q 8,9,10 model, PDA TR 56, and other industry best practices.
• Ensure that quality systems are designed and operate as appropriate to provide support in development and commercialization for GXP areas.
• Evaluate, identify, and drive continuous improvement opportunities to maintain product quality and improve process effectiveness in the overall QMS lifecycle.
• Oversee and manage the electronic Quality Management System (eQMS), including workflow configuration and the continued validation of the system.
• Support inspection readiness activities including assessment and oversight of Kyverna records, storyboard, and inspection logistics.
• Participate in audits and inspections representing Quality Systems.
• Support Regulatory Filings as required.
• Manage a budget for implementation of quality tools and training.
• Support processes and work with contract service providers providing manufacturing and testing and clinical services.
• Manages and mentors a team of highly performing individuals.

Senior Director, Quality Systems

Paralegal

• Provide a diverse range of legal and contract management support within the Legal Department
• Manage a high volume of documents, including end-to-end contract administration
• Ensure contracts are accurately formatted, properly routed, and efficiently executed
• Track and organize agreements, maintaining contract records
• Support workflow optimization using tools such as SharePoint and Ironclad
• Ensure timely contract execution across the organization

Paralegal, Contract Management – Legal Operations

• Lead end-to-end Clinical Data Management activities for assigned clinical studies from study start-up through database lock and archival
• Provide operational leadership for study timelines, deliverables, risks, and quality across internal teams and external vendors
• Oversee key CDM activities including: Database build and validation, eCRF design and review, Edit check specifications, Data review and cleaning, External data reconciliation (e.g., PK, biomarkers, central labs, imaging), Database lock activities, Data transfers for statistical analysis and regulatory submissions
• Review and approve key CDM documentation including: Data Management Plans (DMPs), Data Review Plans, CRF Completion Guidelines, Vendor data transfer specifications, Database validation documentation
• Ensure clinical data are accurate, complete, consistent, and inspection-ready in compliance with timelines and regulatory requirements
• Partner cross-functionally with Clinical Operations, Biostatistics, Statistical Programming, Clinical Development, Regulatory, and Quality to support study execution and submission readiness
• Contribute to the development and implementation of CDM standards, SOPs, processes, and best practices
• Support standardization initiatives aligned with CDISC standards and evolving industry practices
• Drive proactive risk identification, issue escalation, and resolution across study teams and vendors
• Lead and manage CRO/vendor relationships for data management activities, including oversight of quality, timelines, budgets, and performance metrics
• Support governance meetings and vendor performance reviews to ensure accountability and continuous improvement
• Collaborate with cross-functional stakeholders to support data review, reconciliation, and clinical data integrity
• Support inspection readiness activities, audits, and health authority inspections related to clinical data management
• Support process optimization, automation, and innovation to improve operational efficiency and data quality
• Contribute to building a collaborative, high-performing CDM function aligned with company values

Associate Director, Clinical Data Management

• Define, lead and execute the global Clinical Data Management strategy, aligned with Kyverna’s clinical, regulatory and corporate objectives
• Establish and evolve the CDM operating model, governance framework, resourcing strategy and organizational structure to support growth across programs and regions
• Serve as a key member of the Clin Development Operations leadership team, contributing to enterprise-level planning
• Lead the development and implementation of data standards, processes, and technologies, including CDISC and emerging industry best practices
• Drive innovation in data collection, integration, and analytics, including adoption of modern tools and automation
• Oversee standards governance, including management of deviations and continuous improvement initiatives
• Champion a data-driven culture, enabling real-time insights and decision-making across clinical programs
• Provide executive oversight of end-to-end CDM activities across all clinical studies, including: Study start-up planning, EDC/database and CRF design, Data validation, cleaning and reconciliation, Integration of external data (e.g. PK, biomarkers, etc..), Database locks and data transfers for analysis and submission
• Ensure delivery of high-quality, inspection-ready clinical data in line with program timelines and regulatory expectations
• Oversee development and review of key CDM deliverables, including, Data Management Plans (DMPs), edit check specifications, CRF design and completion guidelines and data review plans
• Provide strategic oversight of CDM systems and platforms to ensure scalability, compliance, efficiency, and long-term fit.
• Identify and drive opportunities for process optimization, automation, and innovation in data collection, integration, review and reporting.
• Evaluate emerging technologies, including AI-enabled solutions, to enhance data quality, efficiency, and transparency
• Ensure effective cross-functional data review and reconciliation across internal and external data sources
• Define and execute CDM vendor strategy, including selection, oversight, and performance management of CRO partners
• Provide senior-level oversight of vendor performances, including issue escalation, risk management, quality oversight, and continuous improvement
• Build strong, collaborative relationships with external vendors to ensure quality, efficiency, and scalability
• Drive accountability through KPIs, metrics, and governance frameworks
• Ensure compliance with global regulatory requirements, including 21 CFR Part 11, ICH-GCP, and CDISC standards
• Lead inspection readiness efforts for data management, including robust documentation, audit support and health authority interactions
• Ensure all CDM processes, systems, and documentation meet regulatory and quality standards
• Partner closely with Biostatistics, Statistical Programming, Clinical Operations, Clinical Development, Regulatory, and Quality to support INDs, amendments, DSURs, BLAs and post-marketing commitments
• Provide strategic input into clinical development plans, regulatory submissions, and data deliverables
• Influence cross-functional stakeholders to ensure timely and high-quality data delivery
• Build, lead and mentor a high-performing Clinical Data Management organization
• Foster a culture of ownership, collaboration, accountability, and continuous learning aligned with company values.
• Develop succession plans and capability roadmaps to support organizational growth and future pipeline needs

Executive Director, Clinical Data Management

QA Engineer

• Review executed batch records and associated documentation for accuracy and compliance
• Support batch release and disposition activities
• Must consistently meet production schedule release timelines
• Ability to identify and escalate issues to Quality Management
• Provide quality guidance on documentation discrepancies and compliance issues
• Maintain and update vendor change notifications tracker
• Assist with quality system processes, including deviations, change controls, CAPAs, and vendor change notifications
• Ensure adherence to cGMP regulations, ICH guidelines, and Kyverna SOPs
• Contribute to quality system enhancements and continuous process improvement initiatives
• Perform additional duties as assigned

Senior Specialist, Quality Assurance Operations

• Support the design, development, and execution of clinical studies, with accountability for protocols, clinical documents, and overall study quality in alignment with GCP and regulatory expectations. Including but not limited to:
• Performing comprehensive, ongoing review of clinical trial data (e.g., safety, efficacy, adverse events, laboratory data)
• Identifying data trends, discrepancies, and potential safety signals; escalating findings appropriately
• Generating, tracking, and resolving data queries in collaboration with data management and clinical operations
• Ensuring accuracy, completeness, and consistency of clinical data across systems and reports
• Participating in study start-up and oversight activities, including vendor management and CRO collaboration
• Contribute to site-facing activities, including investigator support, training, and query resolution
• Proactively identify risks and implement mitigation strategies, particularly in areas such as enrollment, site performance, and operational execution.
• Participate in the development, writing, and review of key clinical and regulatory documents, including protocols, clinical study reports, informed consent forms, safety updates, and submission materials.
• Support clinical data review and interpretation, including safety and efficacy data
• Maintain deep understanding of program data and evolving clinical insights
• Support publication and data dissemination strategies, including development of abstracts, presentations, and manuscripts.

Senior Clinical Research Scientist

• Serve as the physician lead for CAR T-cell therapy clinical trials in autoimmune disease indications, in partnership with internal and external cross-functional teams.
• Oversee medical monitoring of clinical trials, including engagement with site investigators and external medical monitors.
• Partner with clinical operations, biometrics, regulatory, and commercial teams to ensure alignment on strategy and execution.
• Lead design, execution, and interpretation of clinical trials across assigned program
• Provide medical and scientific input into clinical development plans, study protocols, investigator brochures, and regulatory submissions.
• Medical review, analysis, and interpretation of safety, efficacy, and PK and biomarker data.
• Development of clinical trial documents including protocols, ICFs, clinical development plans, and publications.
• Lead the development of clinical sections of regulatory documents including the IB, safety updates, clinical study reports, and responses to Health Authorities.
• Actively engage with external investigators and researchers to identify, evaluate, and support investigator sponsored studies and drive research collaborations.

Senior Medical Director, Clinical Development

• Support the operational execution of cell therapy clinical trials with a primary focus on vendor management, including central laboratory oversight.
• Ensure vendors deliver high-quality, timely services aligned with study timelines, budgets, and regulatory requirements.
• Oversee site feasibility, selection, contracting, start-up and close-out activities.
• Conduct Monitoring Oversight Visits as needed.
• Lead vendor oversight through governance structures, issue identification, escalation, and resolution.
• Ensure central lab operational readiness, including lab manual review and site training coordination.
• Partner closely with vendors to ensure timely, accurate data delivery.
• Communicate vendor performance and escalate risks/issues to leadership as needed.
• Contribute to development/review of study documents and support process improvements in vendor governance and central lab operations.