Jobs at Kyverna Therapeutics

The Sr. Director of Marketing Promotions will lead promotional strategies, ensure compliance with regulations, and coordinate with various departments for successful product launches and lifecycle management.

Lead QA operations and strategic quality oversight for CDMOs across plasmid, viral vector, and cell therapy manufacturing. Oversee batch release, batch record review, product disposition, deviations/CAPAs, change controls, and inspection readiness. Drive continuous improvement, monitor quality metrics, and support patient apheresis and lab onboarding to ensure cGMP and regulatory compliance.

Lead and oversee CDMO execution for cell therapy clinical and commercial programs. Drive supplier performance, GMP compliance, audits, change control, investigations, and Person-in-Plant activities. Implement metrics, operational improvements, risk-based quality strategies, and supplier relationship management. Coordinate cross-functional stakeholders, support regulatory readiness, mentor team members, and support due diligence. Travel to manufacturing sites as needed (up to 25%).

Provide high-trust executive support including complex calendar and travel management, meeting logistics, presentations, communications, project coordination, and confidential administrative processes for senior leadership in a biotech environment.

Support QA operations for cell therapy manufacturing: review batch records, support product release and disposition, manage vendor change notifications, oversee deviations/change controls/CAPAs, author and maintain SOPs, support audits and inspection readiness, and drive QMS continuous improvement.

Lead pharmacovigilance operations and safety science for assigned products, overseeing vendor management, case processing quality, signal detection and management, aggregate reporting, risk management plans, regulatory submissions, and inspection readiness in collaboration with cross-functional teams.

Senior leader accountable for integrated development and commercialization strategy of CAR-T programs. Leads lifecycle governance, cross-functional coordination, portfolio prioritization, regulatory and manufacturing readiness, risk assessment, and executive-level decision-making to advance programs from development through regulatory filings and launch.

Lead operational delivery of cell therapy clinical trials from startup through close-out. Manage timelines, budgets, vendors/CROs, cross-functional coordination, regulatory compliance, site activation, monitoring, risk mitigation, audits, and process improvements specific to cell-therapy challenges.

Lead cross-functional program management for engineered T cell therapy development. Translate strategy into integrated plans, track milestones and risks, drive execution and governance, align stakeholders, and build operational processes. May recruit and supervise junior PM staff.

Lead U.S. commercial sales and go-to-market strategy for CAR-T therapies. Build and scale a specialty sales organization, drive launches and market penetration, manage field teams, collaborate cross-functionally on access and site readiness, and use analytics to monitor KPIs and optimize performance.

Lead account and site activation strategies for health systems, IDNs, and treatment centers to enable adoption of cell therapies. Manage onboarding, contracting, operational readiness, certification, logistics, reimbursement support, and cross-functional coordination. Drive expansion initiatives, analyze account performance, build executive relationships, and represent site readiness to senior leadership.

Lead development and execution of a risk-based enterprise compliance program supporting commercialization readiness. Build governance, policies, monitoring, third-party diligence, training, reporting, and investigations. Serve as strategic partner to executive leadership, manage cross-functional initiatives and compliance team growth, and establish metrics to evaluate program effectiveness.

Lead strategy and execution of an in-house Trial Master File (TMF) function, transitioning from outsourced to internal operations. Ensure TMFs are inspection-ready across study lifecycle, manage Veeva Vault eTMF implementations and migrations, define governance and KPIs, partner cross-functionally, and support regulatory inspections and audits.

Lead QC oversight for clinical cell therapy manufacturing and external CMO labs. Own product specifications, stability programs, method validation/transfer, investigation of OOS/OOT events, COA generation, KPI monitoring, and risk-based quality management to support multi-phase clinical programs.

Lead technology strategy and operations for a commercializing biotech: define multi-year roadmap, deploy commercial and enterprise systems, ensure cybersecurity and GxP validation, manage infrastructure, data governance, vendors, and IT teams to support commercialization, regulatory readiness, and operational excellence.

Lead global regulatory strategy for Kyverna's cell therapy portfolio across development, approval, and commercialization. Drive labeling strategy, health authority engagements (FDA, EMA), regulatory submissions (INDs, BLAs/MAAs), and cross-functional alignment with Clinical, CMC, Commercial, Market Access, and Legal. Mentor and scale the regulatory team, manage external partners, and provide regulatory input for business development and portfolio decisions to enable launch readiness and lifecycle management.

Lead discovery and early development strategy for next-generation immune cell therapies. Oversee multidisciplinary teams, evaluate and advance in vivo CAR-T and cellular engineering technologies, build external collaborations, prioritize discovery investments, and partner with clinical, regulatory, and business teams to progress candidates from discovery through IND-enabling development.

Lead development and execution of CAR T channel strategy and operations, overseeing 3PL, specialty pharmacy, distribution, state licensing, government pricing support, GTN optimization, partner governance, launch readiness, reporting, and cross-functional coordination to ensure scalable, compliant commercialization.