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Jade Biosciences
Jade Biosciences
11 – 50 Angajați
Asistență medicalăBiotehnologieIndustria prelucrătoare
Jade Biosciences este o companie de biotehnologie aflată în etapa clinică, care lucrează la dezvoltarea unor terapii noi pentru bolile autoimune. Programul său principal, JADE101, este un anticorp conceput să blocheze APRIL, o citokină implicată în reglarea imunității, și este dezvoltat pentru nefropatia cu imunoglobulina A (IgAN). Compania își dezvoltă portofoliul prin active aflate în etapa de descoperire, licențiate de la Paragon Therapeutics, și avansează programe clinice menite să răspundă unor nevoi semnificative încă nesatisfăcute în îngrijirea bolilor autoimune.
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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.

USStatele Unite ale Americii
180.000 $ – 195.000 $ / an
RemoteNormă întreagăSeniorLimbă Obligatorie: englezăCercetare clinică

Descriere

  • 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

Cerințe

  • 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

Beneficii

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

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