Kyverna Therapeutics este o companie de biotehnologie și produse farmaceutice aflată în etapa clinică, care dezvoltă terapii celulare pentru bolile autoimune. Cercetarea sa se concentrează pe abordări bazate pe celule T cu receptori himerici pentru antigen (CAR T), concepute pentru tratarea afecțiunilor asociate celulelor B și pentru obținerea potențială a unei remisiuni de durată fără tratament. Principalul candidat al companiei, KYV-101, este evaluat în studii clinice pentru afecțiuni precum scleroza multiplă, miastenia gravis, scleroza sistemică și nefrita lupică. Portofoliul de dezvoltare al Kyverna include terapii CAR T autologe și alogene, susținând activitatea companiei în cercetarea și dezvoltarea tratamentelor pentru bolile autoimune.
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.
Statele Unite ale Americii
California320.000 $ – 350.000 $ / an
RemoteNormă întreagăSeniorLimbă Obligatorie: englezăDirectorDescriere
- 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
Cerințe
- 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
Beneficii
- Eligibility for a bonus
- Company benefits
- Participation in the company stock plan