Kyverna Therapeutics

Content Writer

• Author comprehensive safety assessment reports for inclusion in BLA submissions, ensuring scientific accuracy, clarity, and regulatory alignment
• Prepare and draft high-quality responses to FDA Information Requests related to BLA safety content
• Collaborate with Pharmacovigilance, Clinical, Regulatory Affairs, Biostatistics, and Medical teams to ensure consistency and completeness of safety narratives and analyses
• Contribute to integrated summaries of safety, risk-benefit analyses, and other safety sections required for regulatory filings
• Ensure documents comply with FDA, ICH, and global regulatory standards
• Assist in drafting, editing, formatting, and maintaining safety-related SOPs and associated work instructions
• Ensure SOPs align with current regulatory requirements and internal quality standards
• Support inspection readiness activities as needed

Safety Writer – Contract

Director

• Define and lead the global safety and pharmacovigilance strategy across all development stages.
• Serve as the safety subject-matter expert for cell therapy programs, including novel and emerging safety risks.
• Provide strategic safety input to clinical development plans, protocols, investigator brochures, and regulatory submissions.
• Act as a key member of cross-functional governance and program teams.
• Oversee all PV activities including case processing, signal detection, risk management, and aggregate reporting.
• Ensure compliant execution of ICSR reporting, DSURs, PBRERs/PSURs, SUSARs, and safety narratives.
• In collaboration with other team members, maintain safety databases, vendor oversight, and PV agreements (SDEAs).
• Lead safety surveillance activities and ongoing benefit-risk assessments.
• Review and approve safety data, medical assessments, and regulatory safety documents.
• Contribute to Safety Review Committees (SRCs), Data Monitoring Committees (DMCs), and internal safety governance forums.
• Lead safety signal evaluation, escalation, and documentation.
• Ensure compliance with global safety regulations (FDA, EMA, ICH, CIOMS, local health authorities).
• Partner with team lead for regulatory interactions, inspections, and audits.
• Author or oversee safety sections of INDs and BLAs, and responses to health authority inquiries.
• Partner with team members to maintain PV SOPs, processes, and inspection readiness.
• Lead development and lifecycle management of Risk Management Plans (RMPs) and REMS, as applicable.
• Proactively identify and mitigate safety risks associated with cell therapy modalities.
• Support post-marketing safety planning and launch readiness, where applicable.
• Collaborate in the management of external vendors, CROs, and safety service providers.
• Contribute to the operational excellence, continuous improvement, and cost-effective PV operations.

Executive Director, Safety & Pharmacovigilance

Manager

• Support the design, specifications, and development of eCRFs
• Support the design and testing of technical CDM components including edit checks, reports, and listings
• Develop Data Management Plan documents
• Perform comprehensive review of data generated from the clinical study including third party/external data, SAE data and local lab data, as applicable
• Manage effective communication of data issues and discrepancies to study sites via the query management process
• Provide reports, status updates, feedback, and advice to key study stakeholders on the progress of data cleaning and risk identification / mitigation activities
• Ensure CDM activities are performed in compliance with Good Clinical Practice, ICH Guidelines, Kyverna SOPs, regulatory guidelines, and study specific plans.
• Support the filing of eTMF documentation to ensure that an inspection ready environment is maintained throughout the study lifecycle
• Communicates effectively across functions to ensure that all issues are resolved according to guidelines and requirements. Escalates relevant issues to clinical study management team to facilitate timely resolution. Investigates and analyzes possible solutions

Senior Manager, Clinical Data Management

• Establish and lead GCP/GLP/GPV efforts
• Have clinical quality compliance oversight for clinical development programs both in the US and internationally
• Collaborate with internal clinical and nonclinical functions and external parties including consultants, contract auditors, CROs and investigator sites to promote a high level of quality and consistency across and within programs
• Develop the risk-based audit and compliance strategy for all programs
• Independently manage domestic and international risk-based audits of investigator sites, study documents, databases, vendors, partners, and internal systems in compliance with GCP, GLP, and Company policies and procedures
• Assess impact of audit findings on subject safety, data integrity, and business operations
• Support a culture of sustainable compliance; assist project teams in implementing corrective and preventive actions

Director, Clinical Quality

Accounting Manager

• Lead the month-end, quarter-end, and year-end financial close processes
• Own the general accrual process, including contract review and preparation of journal entries
• Manage and oversee end-to-end Accounts Payable operations, providing leadership to an offshore AP team
• Oversee lease accounting activities in accordance with ASC 842
• Maintain and reconcile fixed asset schedules
• Manage the corporate card program
• Monitor and amortize prepaid expenses
• Oversee cash and investment account reconciliations
• Support other Associate Directors of Accounting and provide accounting support for CRO and/or CMO accruals
• Own SOX control execution and documentation for assigned accounting areas
• Prepare audit schedules and financial analytics

Associate Director, Accounting

• Lead the global HEOR and value strategy across pipeline and commercial assets, ensuring alignment with overall corporate, clinical, and access objectives.
• Develop and execute integrated evidence generation plans, including economic models, real-world evidence, patient-reported outcomes, and burden-of-disease studies to support pricing, reimbursement, and access decisions.
• Oversee the design, development, and maintenance of global value dossiers, HTA submissions, payer value narratives, and supporting materials across key markets.
• Partner closely with Clinical Development to embed HEOR endpoints and evidence requirements into clinical trial design and lifecycle planning.
• Collaborate with Market Access and Commercial leadership to support pricing strategy, payer engagement, launch readiness, and post-launch optimization.
• Serve as a senior internal advisor and escalation point on payer, HTA, and value-related questions, translating complex evidence into clear strategic recommendations.
• Build, lead, and mentor a high-performing HEOR and value team, including internal staff and external vendors, consultants, and academic partners.
• Ensure all HEOR activities are conducted in compliance with applicable regulations, industry standards, and internal governance frameworks.
• Monitor evolving global payer, HTA, and policy landscapes to proactively adapt evidence strategies and inform long-term planning.

Senior Director, Market Access, Health Economics, Outcomes Research, Value

Therapist

• Own the complete customer and patient journey from initial patient registration through legally compliant product sale and invoicing.
• Ensure consistent, on-time execution of scheduling, delivery, and patient support across all cellular therapy programs.
• Serve as the single point of accountability for customer operations outcomes, including service quality, operational performance, scalability, and customer satisfaction.
• Serve as a core member of the site activation team, providing executive leadership and operational oversight to design, implement, and scale patient support services in alignment with site readiness, treatment center onboarding, and launch milestones, ensuring seamless integration of patient access, scheduling, reimbursement support, and care coordination workflows from initial site activation through steady-state operations.
• Design, launch, and lead a Kyverna-branded Navigator organization serving as the primary interface for CAR T treatment centers.
• Establish a unified service model and single point of contact for scheduling, logistics coordination, and patient support.
• Drive scale through standardized workflows, technology enablement, and automation.
• Own and govern the end-to-end scheduling ecosystem, including digital scheduling portals and enabling technologies.
• Ensure tight integration between scheduling, manufacturing, logistics, and patient services.
• Partner with IT and Operations to continuously improve system performance, data visibility, and user experience.
• Define the enterprise patient support strategy and operating model.
• Ensure patient support services are fully integrated with scheduling and site operations.
• Build, lead, and develop a high-performing patient support organization focused on consistency, compliance, and quality.
• Provide executive oversight of state licensing, government price reporting, trade policy, distributor operations, and order-to-cash execution.
• Ensure all commercial activities are conducted in full compliance with regulatory, legal, and contractual requirements.
• Partner closely with Finance, Legal, Compliance, and Market Access to manage risk and enable sustainable commercialization.
• Define and execute Kyverna’s distributor and channel strategy aligned with commercial and supply chain objectives.
• Oversee distributor selection, governance, performance management, and continuous improvement.
• Design the future-state customer operations operating model to support pipeline expansion and long-term growth.
• Establish enterprise KPIs, SLAs, governance structures, and performance management frameworks.

Executive Director, Cellular Therapy Operations

General Counsel

• Draft, review, and negotiate a broad range of commercial agreements, including:
• - Commercial site agreements
• - Vendor and supplier agreements
• - Distribution, logistics, and manufacturing support agreements
• - Consulting, advisory board, patient advocacy and speaker agreements
• - Overflow support for clinical, research, and medical affairs-related contracts and confidentiality agreements
• Develop and maintain contract templates and playbooks to support efficient scaling.
• Provide legal guidance to commercialization team including marketing, market access, commercial operations, patient advocacy and medical affairs teams on promotional activities, disease education, and engagement with healthcare professionals.
• Provide legal guidance on go-to-market strategies for a first-in-class or novel cell therapy.
• Support legal aspects of sales, distribution, and commercialization models.
• Advise on pricing, contracting, and reimbursement-related legal considerations in coordination with internal stakeholders.
• Review and advise on promotional materials and commercial communications in coordination with medical and regulatory teams.
• Advise on healthcare compliance matters and regulations impacting commercial activities, including:
• - FDA/EMA (including promotional and labeling requirements) and FTC regulations
• - Anti-Kickback Statute (AKS), False Claims Act (FCA), and other applicable anti-kickback, anti-corruption, and fraud and abuse laws
• - Sunshine Act and other transparency and reporting obligations (e.g., EU disclosure rules)
• - PhRMA Code and applicable state laws
• Partner with compliance to support training, policies, and internal review processes for commercial and medical materials.
• Provide guidance on data privacy and protection matters, including HIPAA and GDPR, particularly in relation to:
• - Patient support programs
• - Registries and real-world evidence initiatives
• - Data-sharing and vendor agreements
• Assist with legal due diligence and integration activities related to partnerships or acquisitions.
• Identify legal and business risks and propose practical, compliant solutions aligned with company objectives.
• Collaborate closely with internal stakeholders to streamline contracting processes and improve operational efficiency.

Director, Corporate Counsel – Commercial

Research Analyst

• Responsible for the monitoring and oversight of clinical trial sites conducting cell therapy clinical studies in compliance with protocol, ICH-GCP, applicable regulatory requirements, and company SOPs.
• Ensure site qualification, initiation, routine monitoring, and close-out visits are performed in accordance with monitoring plans and study timelines.
• Verify informed consent process and documentation for all study participants.
• Conduct source data verification (SDV) and source data review (SDR) to ensure data accuracy and completeness.
• Review and resolve data queries in collaboration with sites and data management.
• Monitor chain of identity (COI) and chain of custody (COC) processes related to cell collection, manufacturing, shipping, and administration.
• Ensure timely and accurate reporting of adverse events (AEs, SAEs), and special safety events per protocol and regulatory requirements.
• Support inspection readiness activities and participate in regulatory inspections or audits as needed.
• Serve as the primary point of contact for assigned clinical trial sites.

Clinical Research Associate

Affiliate Manager

• Own the strategy, delivery, and ongoing optimization of Finance, Accounting, Legal, HR, and Commercial systems to support business growth, operational efficiency, and regulatory compliance.
• Document, analyze, and continuously improve end-to-end business processes and workflows, identifying opportunities for automation and reduction of manual activities.
• Partner closely with functional leaders to understand business needs and translate them into system solutions, including development of business cases, cost-benefit analyses, and ROI assessments for new implementations or enhancements.
• Lead the full system lifecycle from intake and vendor selection through implementation, validation, go-live, and post-launch support, including requirements gathering, configuration, SOX validation, testing, training, and stabilization.
• Establish and manage change control processes and lead system upgrades, patches, and enhancements to ensure system reliability, security, and compliance.
• Champion IT governance by driving consistent application of policies, procedures, and best practices across all G&A systems.
• Ensure the accuracy, completeness, and integrity of SOX-relevant data through system controls, audits, and reconciliations.
• Develop and deliver dashboards, reports, and analytics that provide leadership with clear insights into business performance, system health, and operational KPIs.
• Ensure all supported systems comply with applicable regulatory and privacy requirements, including FDA regulations, GDPR, and other biotech and life sciences standards.
• Develop, maintain, and audit system validation and SOX documentation.
• Implement and enforce security controls to protect sensitive information, including patient data, employee records, and proprietary research.
• Act as an escalation point and hands-on problem solver for critical G&A system issues, balancing strategic leadership with operational execution.
• Collaborate with IT leadership and business stakeholders to define and maintain a cross-functional G&A systems roadmap aligned with corporate priorities.

IT G&A Business Partner

QA Engineer

• Provide enterprise-level leadership for QA Operations supporting clinical and commercial cell and gene therapy programs.
• Ensure consistent, compliant execution of QA oversight across manufacturing, testing, packaging, labeling, and distribution activities.
• Establish and maintain a scalable, phase-appropriate QA operating model aligned with Kyverna’s growth trajectory.
• Ensure inspection readiness across all programs and sites; lead preparation for and management of global regulatory inspections.
• Provide strategic input into regulatory submissions, responses, and agency interactions related to QA operations.
• Serve as the primary QA point of accountability for external CMOs, CDMOs, contract laboratories, and other GxP service providers.
• Lead qualification, oversight, performance monitoring, and remediation of external partners, including audits and governance forums.
• Ensure quality agreements are in place, effective, and consistently executed.
• Serves as QA leader in quality-related discussions, investigations, risk assessments, change controls, etc. to resolve potential product quality issues and to ensure they are appropriately addressed and justified.
• Provides QA compliance expertise and guidance in conducting investigations in regards to quality deviations, laboratory investigations, change controls, etc.
• Partner closely with CMC, Manufacturing, Technical Development, Supply Chain, Clinical Operations, and Regulatory Affairs to enable compliant and efficient execution.
• Provide quality leadership in program, manufacturing, and operational decision-making, balancing risk, compliance, and speed.
• Influence and lead by example as a quality advocate while maintaining a pragmatic, solutions-oriented mindset.
• Drive process optimization, digital enablement, and standardization across QA Operations.
• Identify and mitigate quality and compliance risks proactively.
• Contribute to Quality and company-level strategic planning initiatives.

Senior Director of Quality Assurance Operations

Compliance

• Responsible for the end-to-end execution and oversight of regulatory submissions across the company’s cell therapy portfolio.
• Ensure high-quality, compliant, and timely regulatory submissions to global health authorities, including FDA, EMA, and other international agencies.
• Leads planning, preparation, publishing, and lifecycle management of regulatory submissions (e.g., INDs, IMPDs, amendments, annual reports, meeting packages, BLAs/MAAs).
• Manage submission timelines, content readiness, and cross-functional coordination to support regulatory milestones.
• Develop, maintain, and optimize regulatory operations processes, SOPs, templates, and best practices.
• Perform Regulatory Submission and Correspondence archival, ensuring version control, and inspection-ready documentation.
• Provide support for Regulatory deliverables in GCP Inspection Readiness.
• Partner closely with Regulatory Affairs strategy leads, CMC, Clinical Development, Medical Writing, Quality, and external vendors.
• Support health authority interactions by preparing and managing briefing packages and response submissions.
• Act as a subject matter expert in regulatory operations, advising on evolving global regulatory requirements and electronic submission standards.
• Drive continuous improvement initiatives to enhance submission quality, speed, and scalability.

Senior Manager, Regulatory Operations

• Provides enterprise-level strategic and operational leadership for Quality Control activities supporting both development and commercial programs.
• Serves as the primary point of accountability for QC oversight across the organization, including outsourced testing networks, stability programs, regulatory submissions, and global inspection readiness.
• Partners closely with Technical Development, Quality Assurance, Regulatory Affairs, and other cross-functional stakeholders to ensure compliance with global regulatory requirements while enabling efficient pipeline advancement and commercial execution.
• Responsible for building and sustaining a scalable, inspection-ready QC organization.
• Drives continuous improvement across the quality system, provides strategic input into program and manufacturing decisions, and represents QC to the executive level.
• Has significant influence on regulatory outcomes, operational performance, and the overall credibility of the company’s quality function.