Kyverna Therapeutics is a clinical-stage biotechnology and pharmaceutical company developing cell therapies for autoimmune diseases. Its research centers on CAR T-cell approaches designed to address B cell-driven conditions and potentially achieve sustained, treatment-free remission. The company’s lead candidate, KYV-101, is being evaluated in clinical trials for conditions including multiple sclerosis, myasthenia gravis, systemic sclerosis, and lupus nephritis. Kyverna’s pipeline includes both autologous and allogeneic CAR T-cell therapies, supporting its work across autoimmune disease research and development.
Senior Director of Safety and Pharmacovigilance (California Remote)
Lead global safety and pharmacovigilance strategy for Kyverna Therapeutics’ autoimmune cell therapy pipeline. Oversee signal detection, risk management, regulatory compliance, and clinical safety activities.
Description
- Serve as the safety subject-matter expert for cell therapy programs in MS, MG, and other designated indications, including novel and emerging risks
- Provide strategic safety guidance for clinical development plans, protocols, investigator brochures, and regulatory submissions
- Participate as a core member of cross-functional governance and program teams
- Oversee medical safety work, including individual case assessment, signal detection, risk management, and aggregate reporting
- Direct safety surveillance and ongoing benefit-risk evaluations
- Review and approve safety data, medical assessments, and regulatory safety documentation
- Support Safety Review Committees, Data Monitoring Committees, and internal safety governance forums
- Lead the evaluation, escalation, and documentation of safety signals
- Maintain compliance with global safety requirements from the FDA, EMA, ICH, CIOMS, and local health authorities
- Work with the team lead on regulatory interactions, inspections, and audits
- Author or oversee safety sections of INDs and BLAs, along with responses to health authority questions
- Collaborate with colleagues to maintain pharmacovigilance SOPs, processes, and inspection readiness
- Identify and mitigate safety risks associated with cell therapy modalities
- Support operational excellence and continuous improvement across the GSP department
Requirements
- MD degree
- At least 12 years of pharmacovigilance and drug safety experience, including 5 or more years in a leadership position
- Direct cell or gene therapy experience, or experience with autoimmune or CNS indications such as MS or MG, is strongly preferred
- Experience working in a clinical-stage biotechnology company
- Previous BLA, MAA, and/or product launch experience is advantageous
- Demonstrated success engaging global regulatory agencies on safety matters
- Strong command of global pharmacovigilance regulations and safety standards
- Ability to work hands-on within a lean organization
- Excellent cross-functional leadership and communication abilities
- Proven ability to balance compliance, scientific rigor, and business priorities
Benefits
- Eligibility for a bonus
- Company benefits
- Participation in the company stock plan