Kyverna Therapeutics

Director

• Identify life-cycle management process improvement options that improve robustness, increase capacity, and reduce cost of goods to support the company’s aspirations to be the leader in the autoimmune CAR T space.
• Partner with the life-cycle team leaders, clinical development, commercial, and business development teams to create the optimization and innovation roadmap.
• Identify opportunities for team synergies and/or product improvements across different products and platforms.
• Lead the process development function including the in-house laboratories.
• Manage the design and execution of process development plans, including studies that support pre-clinical and clinical development stages.
• Design process characterization plans and process control strategies.
• Support the optimization of plasmids, vectors, and product delivery methods.
• Lead the execution of laboratory studies, technical assessments for engineering and process changes, and documentation generation pertaining to process development, qualification, and validation.
• Oversee the execution of studies that support process development, process characterization, and life-cycle change management to ensure on time delivery of projects.
• Author and review process related documents, including risk assessments, technical protocols and reports, batch records, change controls, investigation reports, and corrective and preventative actions.
• Author and review CMC sections of regulatory documents in support of both clinical trial (IND/IMPD) and commercial therapeutic applications (BLA/MAA).
• Support the characterization of critical raw materials (cell banks, plasmids, reference standards, etc.).
• Support the creation of the product supply strategy, including assessments for in-house versus outsourced activities.
• Design processes that ensure compliance with Good Manufacturing Practices (cGMP) and other regulatory requirements.
• Manage the tech transfer for clinical and commercial manufacturing.
• Collaborate and communicate effectively with Kyverna Leadership, Analytical Development, Manufacturing, Quality, Clinical and Regulatory teams and with external business partners and Regulatory Authorities.

Senior Director, Process Development

• Provide process development leadership for new process development, optimization of existing processes, associated process equipment, technology transfer, and support for GMP manufacturing of engineered T cell therapy products.
• Lead process-related risk assessments, process characterization plans, and development of process control strategies.
• Lead and mentor a team of scientists and engineers through strong leadership, collaboration, and a results-driven mindset.
• Serve as the primary responsible and accountable leader for the execution of wet lab process development and process characterization activities.
• Define and lead laboratory studies and technical assessments for engineering and process changes, and oversee documentation related to process development, qualification, and validation to meet regulatory requirements.
• Author and review process-related documents including risk assessments, technical protocols and reports, batch records, change controls, investigation reports, and corrective and preventive actions (CAPAs).
• Author and review CMC sections of regulatory submissions supporting clinical trial applications (IND/IMPD) and commercial applications (BLA/MAA).
• Develop and implement plans and studies required to incorporate new technologies that support the mission and pipeline needs of the organization.
• Plan and oversee studies supporting process development, process characterization, and lifecycle change management to ensure timely and complete delivery aligned with development timelines.
• Serve as the accountable technical interface between Kyverna Process Development and CDMO partners to manage process development and process characterization activities supporting engineered cell-based therapy programs.
• Support CMC and product development teams through robust data analysis, process development execution, and integration of manufacturing and development strategies within CMC functions.
• Maintain current awareness of GMP/GTP regulations, guidance documents, advisory committee updates, industry standards, and emerging trends relevant to Cell Therapy Development operations and products.
• Establish and maintain strong cross-functional partnerships with Analytical Development, Manufacturing, Quality, Clinical, and Regulatory teams.

Director, Process Development

• Develop and execute a global training strategy tailored to cell therapy programs across clinical and commercial stages.
• Build role-specific onboarding, certification, and continuous learning pathways for Medical and Commercial teams and other teams as appropriate.
• Independently design and develop training content while overseeing and leveraging support from external vendors.
• Deliver comprehensive training—including disease state education, unmet medical needs, CAR T product design and manufacturing, clinical data, safety monitoring and management.
• Plan and lead virtual and onsite onboarding and refresher programs for Medical and Commercial field teams and other teams within the organization as appropriate.
• Partner cross-functionally with Medical Affairs, Clinical Development, CMC, Regulatory, Quality, Commercial, and Patient Services to align training with launch readiness and lifecycle strategy.
• Ensure all training materials and certification processes meet FDA, EMA, and global compliance standards.
• Implement structured field excellence programs focused on high quality and impactful scientific exchange, KOL engagement, and insight generation.
• Develop and implement learning systems and training analytics, establishing KPIs to measure competency, certification, and launch preparedness.
• Partner with HR on establishing company-wide onboarding programs for new employee orientation on Kyverna’s products and programs.

Director of Training – Global Medical Affairs

Therapist

• Maintain relationships with suppliers including but not limited to transportation providers, specialty couriers, and customs brokers to generate proposals, manage change notifications, and ensure timely delivery.
• Plan and execute high touch patient material shipments (in LN2 solutions) based on cross functional schedule to/from clinical or commercial sites with couriers.
• Monitor shipments in real time and proactively identify, escalate, and resolve delays, excursions, or logistical risks to protect patient schedules.
• Serve as a central communication hub for real-time logistics updates, ensuring stakeholders receive timely and accurate information.
• Collaborate closely with Patient Operations, Manufacturing, Technical Development, Supply Planning, Quality, and CDMO partners to plan and align logistics with patient treatment timelines and study requirements.
• Provide on-call support and troubleshooting during active transports to address urgent or non-routine issues.
• Develop and implement logistics strategies to ensure global supply availability.
• Develop and implement material management strategies to ensure inventory of critical raw materials is available at all times, with mitigations in place for waste reduction.
• Partner with Supply Chain Planning, program leads, CMC, development teams, and suppliers to generate proposals, place purchase requisitions, and track material procurement.
• Maintain accurate records to support audit readiness and quality requirements.
• Identify continuous improvement initiatives to optimize Kyverna’s supply chain and implement accordingly with guidance from supply chain leadership.
• Review courier invoices, support budget tracking, and manage supplier performance monitoring and optimization initiatives.
• Perform other duties as assigned.

Cell Therapy Supply Chain Manager

Manager

• Serve as the lead statistician for assigned individual clinical studies, providing hands-on support for study design, power and sample size calculations, statistical analysis plans, TFL shells, and interpretation of results
• Execute and oversee statistical analyses, including review of tables, listings, and figures generated by internal teams or CROs
• Prepare and review statistical methods and results sections for clinical study reports and contribute to integrated analyses
• Provide statistical guidance on study design, data collection, data review, and analysis for clinical trials
• Support efficient medical and safety data review and monitoring activities, including participation in DSMB meetings as needed
• Contribute to the development and review of statistical components of regulatory submissions and responses to health authority questions
• Support protocol development, amendments, and data review meetings with cross-functional teams
• Review clinical study documentation for eCTD submissions, including familiarity with CDISC standards, SDTM, ADaM, and define.xml
• Collaborate closely with clinical operations, data management, medical, regulatory, and safety teams to support global study execution
• Contribute to continuous improvement of statistical processes

Senior Manager, Biostatistics

Business Development Rep

• Serve as a senior leader within the Business Development organization, with primary responsibility for driving in-bound and out-bound business development transactions, including strategic partnerships, licensing (in-licensing and out-licensing), and research collaborations.
• Proactively identify, evaluate, and prioritize external partnering opportunities that align with the Company’s scientific platform, pipeline priorities, and long-term growth strategy.
• Build, develop, and maintain senior-level relationships with biopharmaceutical companies, biotechnology partners, academic and research institutions, and other strategic stakeholders to advance the Company’s partnering objectives.
• Lead cross-functional deal teams through the end-to-end transaction lifecycle, including:
• Development of strategic rationale and investment thesis
• Opportunity screening and prioritization
• Financial valuation, scenario analysis, and deal modeling
• Scientific, commercial, operational, and legal due diligence
• Deal structuring, negotiation, and execution in close collaboration with Legal, Finance, and the Chief Business Officer
• Prepare and present deal recommendations and transaction materials to the executive leadership team and Board of Directors, including strategic fit, value creation, risks, and alternatives.
• Support development and management of the BD pipeline, including tracking opportunities, competitive intelligence, and deal trends.
• Represent the Company at partnering meetings, industry conferences, and key external events, serving as a senior ambassador for the Company’s strategy, science, and partnering priorities.
• Lead alliance management activities with existing strategic partners including oversight of governance, issue escalation and relationship management.

Senior Director, Business Development

• Provide quality expertise supporting the development and commercialization of Kyverna’s products in compliance with relevant US, EU, and ICH requirements.
• Actively manage, develop, implement, and report on Quality Systems, including Deviations, Investigations, CAPAs, Change Controls, Quality Metrics, and electronic Quality Management Systems (eQMS).
• Serve as a subject matter expert and strategic partner across Technical Operations, Clinical, Regulatory Affairs, and other cross-functional teams.
• Oversee execution, scalability, and continuous improvement of Kyverna’s Quality Management System as the organization grows and matures.

Senior Manager, Quality Systems

Affiliate Manager

• Manage the strategy and execution of GxP R&D, Clinical and Commercial systems to ensure efficiency, scalability, and compliance with company needs.
• Document, analyze, and optimize the current business processes and workflows to identify opportunities for improvement and automation to reduce manual processes.
• Partner with business leaders to understand their needs, develop business cases for new system implementations or enhancements, including cost-benefit analysis and return on investment (ROI) calculations.
• Lead full lifecycle of system implementation from selection through go-live support, including request for projects, requirements gathering, system configuration, validation, testing, training, and post-go-live support.
• Create change controls and lead system upgrades, patches, and enhancements to maintain system functionality and security compliance.
• Champion IT governance and compliance, driving continuous improvement of policies, procedures, and best practices for GxP system implementation and validation.
• Ensure the accuracy and integrity of GxP data through system audits and reconciliations.
• Develop and deliver actionable dashboards and reports to provide leadership with insights into business performance, system health, and operational metrics.
• Ensure all systems comply with FDA regulations, GDPR, and other biotech-related regulatory standards.
• Develop system validation documentation and manage validation engineers.
• Implement, document, and maintain proper security protocols to safeguard sensitive company information, such as patient data, employee information, and proprietary biotech research.
• Act as escalation point and hands-on problem solver for critical GxP system issues, balancing strategic oversight with operational responsiveness.
• Partner with IT leadership to create cross functional roadmap of GxP systems

Senior Manager, IT GxP Business Partner

Accounting Manager

• Lead the preparation and filing of all SEC reports, including Forms 10-K, 10-Q, 8-K, S-8, and other required filings. Oversee XBRL tagging and coordinate closely with internal stakeholders and external service providers to ensure timely and compliant submissions.
• Ensure compliance with U.S. GAAP, SEC regulations, and other applicable financial reporting requirements.
• Own the evaluation and documentation of complex accounting matters, including the adoption of new accounting standards. Prepare and maintain technical accounting position papers and ensure alignment with SOX controls and documentation requirements. Support the monthly and quarterly financial close processes and internal and external reporting.
• Serve as the in-house revenue recognition expert in support of the Company’s upcoming product launch. Establish GAAP- and SOX-compliant accounting and reporting processes for commercialization. Partner cross-functionally with Market Access, Commercial, Finance, and IT to support the implementation and optimization of order-to-cash system solutions.
• Provide technical accounting support for complex transactions, including equity and debt financings, licensing arrangements, and collaboration agreements. Participate in assessing accounting and reporting implications associated with the Company’s commercialization strategy.
• Manage the external audit process, including coordination of quarterly reviews and annual audits. Oversee preparation and delivery of PBC materials and serve as the primary liaison with external auditors on technical accounting matters.
• Lead equity accounting, including calculation and recording of stock-based compensation in accordance with ASC 718 and other applicable standards. Oversee the work of the stock administration consultant responsible for day-to-day equity operations. Support Section 16 reporting and related compliance requirements in coordination with external legal counsel.
• Establish, enhance, and maintain efficient processes and strong SOX internal controls across SEC reporting, technical accounting, and equity administration.
• Partner with Investor Relations and the Controller to support the preparation of quarterly earnings releases, financial tables, annual reports, and proxy statements. Assist in preparing compensation, benefits, and share-based compensation disclosures and related proxy filings.
• Develop, update, and communicate accounting policies as needed to ensure clarity, consistency, and timely adoption across the organization.

Director, SEC Reporting and Technical Accounting

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

• 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.