Kyverna Therapeutics autoimmun kasalliklar uchun hujayra terapiyalarini ishlab chiqayotgan klinik bosqichdagi biotexnologiya va farmatsevtika kompaniyasidir. Uning tadqiqotlari B hujayralari bilan bog‘liq kasalliklarni nishonga olish hamda uzoq muddatli, davolashsiz remissiyaga erishish imkoniyatini ko‘zlagan CAR T-hujayra yondashuvlariga qaratilgan. Kompaniyaning asosiy nomzod preparati KYV-101 ko‘p skleroz, miasteniya gravis, tizimli skleroz va qizil yugurik nefrit kabi kasalliklar bo‘yicha klinik sinovlarda baholanmoqda. Kyverna kompaniyasining ishlab chiqish dasturiga autoimmun kasalliklarni tadqiq etish va rivojlantirish ishlarini qo‘llab-quvvatlovchi autologik va allogenik CAR T-hujayra terapiyalari kiradi.
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.
Amerika Qo‘shma Shtatlari
Kaliforniya320 000 $ – 350 000 $ / yil
MasofaviyTo‘liq stavkaSeniorTalab Qilinadigan Til: inglizchaDirektorTavsif
- 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
Talablar
- 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
Imtiyozlar
- Eligibility for a bonus
- Company benefits
- Participation in the company stock plan