Kyverna Therapeutics

Manager

• Support maintenance and execution of global publication plans across therapeutic programs
• Manage end-to-end activities for publication projects (ie, manuscripts, abstracts, posters, and presentations), such as author invitations, sending and tracking reviews and approvals, filing, timelines, and submissions
• Maintain publication project trackers and proactively communicate with publication lead, writers, internal reviewers, and external authors
• Ensure publication development processes are followed in a compliant, organized, and timely manner
• Proactively coordinate with external vendors and medical writers to ensure high-quality deliverables
• Ensure compliance with internal policies and external publication guidelines (e.g., ICMJE, GPP)
• Support planning and execution of key scientific congresses and medical meetings (regional and global)
• Coordinate logistics for conference participation including abstracts, booths, hotels, transportations, dinners, and other events
• Assist with vendor coordination, including agencies, venues, and production partners
• Communicate with external advisors, speakers, and KOLs for meeting and event planning purposes
• Support contracting, budget tracking, purchase orders, and expense reconciliation
• Coordinate internal communications and materials for conference readiness
• Assist in planning and execution of advisory boards and HCP engagement events

Publications & Conferences Manager – Consulting

Communications

• Lead the development and lifecycle management of the global, integrated publication strategy across Kyverna’s therapeutic pipeline, ensuring alignment with clinical milestones, regulatory timelines, and Medical Affairs priorities.
• Drive end-to-end execution of scientific publications, including manuscripts, abstracts, posters, oral presentations, and case reports, ensuring scientific rigor, clarity, and consistency across all deliverables.
• Serve as the primary owner of publication deliverables, accountable for timelines, quality, authorship strategy, and compliance across all outputs.
• Lead and facilitate cross-functional Publication Team meetings, partnering closely with Clinical Development, Biostatistics, Regulatory, Medical Affairs, and other stakeholders to ensure accurate interpretation and communication of clinical data.
• Translate complex clinical trial data into compelling, scientifically accurate narratives that support scientific exchange and external engagement.
• Independently write, edit, and critically review scientific and medical content, while providing strategic oversight of external medical writers and publication vendors.
• Manage relationships with external collaborators, including key opinion leaders (KOLs), authors, and agencies, ensuring efficient coordination and high-quality outputs.
• Oversee publication review processes, incorporating cross-functional feedback while maintaining scientific integrity and alignment with communication objectives.
• Ensure full compliance with GPP, ICMJE, and internal SOPs, including appropriate documentation, transparency, and authorship standards.
• Integrate publication planning with congress strategy, supporting abstracts, presentations, and related scientific communication activities aligned with key congress milestones.
• Develop and maintain deep expertise in disease areas, product data, and the competitive landscape to inform publication strategy and messaging.
• Identify and implement process improvements, tools, and best practices to enhance publication efficiency, quality, and scalability.
• Stay current with industry trends, innovations, and emerging practices in scientific communications and publications.
• Develop and support other medical communications deliverables, including slide decks, advisory boards, and symposia, as needed.
• Attend key scientific congresses to support execution and gather insights on evolving science and competitive intelligence.

Associate Director, Medical Communications

Engineer

• Execute validation activities for GxP computerized systems using a risk-based Computer Software Assurance (CSA) approach.
• Author and maintain validation deliverables, including Validation Plans, Risk Assessments, Test Scripts and Protocols, and Validation Summary Reports.
• Support full system lifecycle activities, including implementation, change control, periodic review, and system retirement.
• Ensure all validation documentation is inspection-ready and aligned with internal procedures and global regulatory requirements.
• Partner with IT and business stakeholders to support onboarding and implementation of new systems.
• Provide validation guidance during system selection, configuration, and release to ensure compliance and scalability.
• Participate in change control assessments, evaluating the impact of system changes and enhancements on validated state.
• Serve as the validation lead for key GxP platforms, including Veeva Vault (eQMS, QualityDocs, Training) and other regulated systems.
• Ensure systems remain in a validated state in compliance with 21 CFR Part 11, EU Annex 11, and data integrity principles, including ALCOA+.
• Collaborate with IT and system owners to support system enhancements, releases, and ongoing periodic reviews.
• Support IT due diligence and qualification of third-party vendors and supplier systems used in GxP environments.
• Assess supplier validation packages, documentation, and control frameworks to ensure compliance with internal and regulatory standards.
• Partner with Quality to evaluate risks, define mitigation strategies, and maintain effective supplier oversight.
• Maintain continuous inspection readiness by ensuring completeness and accuracy of validation documentation, audit trails, and supporting artifacts.
• Support internal audits, mock inspections, and regulatory inspections, including direct interaction with agencies such as the U.S. Food and Drug Administration and European Medicines Agency.
• Proactively identify compliance gaps and drive remediation efforts to strengthen the overall validation and quality posture.
• Act as the primary IT partner to Quality for validation, compliance, and data integrity-related activities.
• Collaborate cross-functionally with Quality Systems, Clinical QA, Regulatory, and other GxP functions to align on validation strategy, risk management, and governance.
• Support the development and continuous improvement of validation procedures, templates, and processes.
• Provide training and guidance to system owners and stakeholders on validation requirements and best practices.

IT Validation Engineer

General Counsel

• Draft, revise, negotiate, and manage a wide range of contracts and documents, including clinical trial agreements, informed consent forms, NDAs, MSAs, CRO Agreements, MTAs, DPAs, consulting/professional services agreements, SOWs, amendments, change orders and various other vendor agreements.
• Work closely with various internal clients to ensure contracts accurately convey desired terms, while minimizing risk.
• Ensure efficient negotiation and project management of the contract life cycle in support of Clinical Development timelines.
• Identify and be able to communicate risks appropriately to internal stakeholders and provide guidance for resolution.
• Ensure continuity and improvement in the quality, efficiency, and effectiveness of contracting systems, processes, and procedures, including the development of templates, fallback language, negotiation guidelines, and escalation protocols, in collaboration with the AGC.
• Act as the primary legal point of contact for the Clinical Development organization, including Clinical Operations, Regulatory, Quality, Med Affairs, Biostats, Safety, and Translational Sciences
• Identify and appropriately manage contract-related risks, including subject injury, data privacy, indemnification, and IP provisions
• Ensure alignment of clinical contracts with applicable regulatory frameworks
• In collaboration with the Head of Procurement, support contractual engagement of CROs and other clinical vendors
• Address country-specific contracting and global clinical trial execution

Senior Contracts Counsel – Clinical

Auditor

• Lead and execute internal audits across GMP, GCP, and GPV systems and associated functions, ensuring timely follow-up through CAPA implementation
• Conduct GxP audits in accordance with applicable regulatory requirements, including preparation of detailed audit reports and oversight of corrective and preventive actions
• Apply strong knowledge of clinical and CMC development processes to manage and continuously improve the internal GxP audit program
• Independently manage multiple priorities, solve complex problems, and maintain a high level of inspection readiness
• Support external audits and regulatory inspections, partnering closely with cross-functional teams
• Represent Quality Vendor Management in cross-functional meetings, contributing to aligned and compliant decision-making
• Oversee the GxP vendor and supplier management program to ensure compliance with regulatory standards and internal requirements
• Perform risk assessments and drive continuous improvement initiatives to strengthen quality and compliance frameworks
• Author, review, and update SOPs to ensure alignment with evolving regulatory expectations and business needs
• Develop and implement tools and processes to enhance audit consistency, efficiency, and overall compliance
• Support inspection readiness activities and collaborate with stakeholders to ensure organizational preparedness
• Ensure supplier management processes, including qualification and ongoing oversight, are executed in accordance with SOPs and KPIs
• Support the development and maintenance of Quality Agreements and supplier contracts as needed
• Escalate critical findings to appropriate management and ensure timely and effective resolution in line with company procedures
• Lead the development and monitoring of supplier performance metrics to proactively identify risks and mitigate compliance issues
• Maintain and manage the approved supplier list to ensure accuracy and compliance

Senior Manager, GxP Auditor – GCP, GMP

Compliance

• Provide strategic and operational regulatory leadership across Kyverna's cell therapy portfolio, with a focus on commercial readiness, labeling strategy, and health authority engagement.
• Lead global regulatory strategy for Kyverna's development programs, aligning clinical, CMC, and commercial objectives from early development through post-approval lifecycle management.
• Provide regulatory input to program governance, asset prioritization, and portfolio decisions, including scenario planning and risk mitigation.
• Anticipate and address regulatory challenges related to cell therapy development, manufacturing, comparability, and long-term follow-up.
• Serve as the primary senior regulatory interface with FDA, EMA, and other global health authorities.
• Lead and/or support key regulatory meetings, including INTERACT, pre-IND, End-of-Phase, pre-BLA/MAA, Advisory Committees, and post-marketing commitments.
• Drive regulatory negotiation strategy, including benefit-risk, endpoints, comparability, and post-approval requirements.
• Own and drive labeling strategy from early development through approval, ensuring labels support commercial differentiation, patient access, and lifecycle value.
• Lead development of Target Product Profiles (TPPs) and ensure alignment across Clinical, Regulatory, Commercial, and Market Access.
• Partner with Commercial, Medical Affairs, and Market Access to ensure regulatory decisions support launch readiness, promotional strategy, and payer engagement.
• Lead label negotiations with health authorities, balancing scientific evidence, regulatory expectations, and commercial objectives.
• Oversee and contribute to the preparation, review, and submission of INDs, CTAs, BLAs/MAAs, briefing packages, orphan drug applications, and other regulatory filings.
• Ensure submissions are high-quality, compliant, and strategically positioned.
• Maintain oversight of submission timelines, dependencies, and risk management, providing clear communication to senior leadership.
• Act as a strategic partner to Clinical Development, CMC, Research, Commercial, Legal, BD, and Alliance Management teams.
• Provide regulatory due diligence and strategic input for business development, in-licensing, out-licensing, and partnership opportunities.
• Oversee regulatory activities performed by CROs, consultants, and partners, ensuring quality and strategic alignment.
• Lead, mentor, and scale a high-performing regulatory team, fostering accountability, development, and a culture of collaboration.
• Establish and maintain regulatory policies, procedures, and infrastructure to support a growing, late-stage organization.

Publications & Conferences Manager – Consulting

Associate Director, Medical Communications

IT Validation Engineer

Senior Contracts Counsel – Clinical

Senior Manager, GxP Auditor – GCP, GMP

Executive Director, Regulatory Affairs