Jade Biosciences
Jade Biosciences
Jade Biosciences — аутоиммунды ауруларға арналған жаңа емдеу әдістерін әзірлеп жатқан клиникалық кезеңдегі биотехнологиялық компания. Компанияның негізгі бағдарламасы JADE101 — иммундық реттелуге қатысатын цитокин APRIL-ді бөгей алатындай етіп жасалған антидене және ол иммуноглобулин A нефропатиясын (IgAN) емдеуге әзірленуде. Компания Paragon Therapeutics лицензиялаған зерттеу кезеңіндегі активтер негізінде өз құбырын қалыптастырып, аутоиммунды ауруларды емдеудегі елеулі қанағаттандырылмаған қажеттіліктерді шешуге бағытталған клиникалық бағдарламаларды ілгерілетуде.

Senior Clinical Trial Manager - United States Remote

Lead clinical operations for Jade Biosciences’ autoimmune disease therapies across Phase 1–3 trials. Coordinate CROs, budgets, vendors, sites, compliance, and study delivery.

Сипаттама

  • Support the Director, Clinical Operations, with the planning and execution of assigned clinical trials
  • Coordinate daily activities among cross-functional teams, clinical sites, CROs, and vendors
  • Maintain study plans, timelines, budgets, risk records, and essential documentation
  • Manage vendor deliverables, performance metrics, issue resolution, meeting governance, invoices, and scope tracking
  • Maintain trial budgets and forecasts, review invoices, monitor spending, investigate variances, and escalate financial risks
  • Maintain risk, issue, decision, and action logs while driving mitigation and resolution
  • Provide operational input for protocols, monitoring plans, informed consent forms, investigator brochures, manuals, and clinical study reports
  • Oversee study start-up, site activation, enrollment, conduct, monitoring, closeout, and inspection-readiness activities
  • Support investigator meetings and monitoring oversight
  • Develop effective working relationships with clinical sites, investigators, CROs, vendors, and internal stakeholders
  • Review study performance metrics and implement corrective and preventive actions
  • Ensure trial activities and documentation follow protocols, Good Clinical Practice, regulations, contracts, and company procedures
  • Coordinate operational requirements and timelines across clinical supply, laboratories, data management, safety, biostatistics, medical monitoring, and regulatory functions
  • Maintain an accurate, inspection-ready Trial Master File and support audits, inspections, and quality oversight
  • Mentor Clinical Trial Associates and Clinical Trial Managers, improve processes, and prepare study updates for governance and senior leadership

Талаптар

  • Bachelor’s degree plus 10+ years of relevant experience for the Senior Clinical Trial Manager role, or 7+ years of relevant experience for the Clinical Trial Manager role
  • Clinical trial management experience in a biopharmaceutical company
  • Ability to independently manage complex trial activities, timelines, vendors, budgets, risks, and cross-functional deliverables, with appropriate escalation
  • Experience supporting Phase 1 through Phase 3 clinical trials
  • Experience managing CROs and clinical vendors, including laboratories, RTSM, EDC, and ancillary clinical technologies or applications
  • Strong working knowledge of FDA regulations, ICH guidelines, Good Clinical Practice, medical terminology, and clinical trial conduct
  • Working knowledge of clinical protocol implementation, regulatory submissions, Trial Master File requirements, and the broader drug development process
  • Excellent communication, organization, collaboration, problem-solving, and attention-to-detail skills, with the ability to manage competing priorities
  • Authorization to work in the United States, verified through Form I-9 and E-Verify

Артықшылықтар

  • Remote work
  • Periodic travel for team and company events
  • Equal Opportunity employment

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