About Jade Biosciences

Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies that address critical unmet needs in autoimmune diseases. Jade’s lead candidate, JADE101, targets the cytokine APRIL, and is currently being evaluated for the treatment of immunoglobulin A nephropathy. Jade’s pipeline also includes JADE201, an afucosylated anti-BAFF-R monoclonal antibody, as well as JADE301, an anti-IFN-β monoclonal antibody. Jade was launched based on assets licensed from Paragon Therapeutics, an antibody discovery engine founded by Fairmount. For more information, visit JadeBiosciences.com and follow the Company on LinkedIn.

Role Overview

The Sr/Clinical Trial Manager will support the Director, Clinical Operations, who is the cross functional clinical trial leader, in the planning and operational execution of assigned clinical trials. This individual will coordinate day-to-day study activities across cross-functional partners, clinical sites, CROs, and other vendors; maintain study plans, timelines, budgets, risks, and key documentation; and escalate issues with clear recommendations. The Senior/Clinical Trial Manager will serve as a primary operational contact for assigned responsibilities, vendors, and regions and help ensure trials are delivered on time, within budget, and in compliance with applicable regulations, Good Clinical Practice, and company standards.  With a proven track record of clinical trial management, financial acumen, and problem-solving skills, this individual will thrive in Jade’s dynamic environment. This is an exciting opportunity to make significant contributions to Jade’s immunology pipeline, managing trials from first in human single site to global (APAC, LATAM, etc.) phase 3.

Key Responsibilities

• Support the development, maintenance, and execution on detailed study operational plans, timelines, enrollment projections, and tracking tools in alignment with program strategy and Director guidance 
• Responsible for vendor oversight activities, for assigned vendors, including deliverables, performance metrics, issue resolution, meeting governance, invoices, and scope tracking; supports vendor selection and Scope of Work development 
• Maintain clinical trial budgets and forecasts; review invoices, track committed and actual spend, identify variances, and escalate financial risks to the Director 
• Maintain study risk, issue, decision, and action logs; drives mitigation and resolution activities and promptly escalates material risks with recommended options 
• Coordinate operational input into the development, review, and implementation of clinical documents, including protocols, monitoring plans, informed consent forms, investigator brochures, pharmacy and laboratory manuals, and clinical study reports 
• Oversee global or regional study start-up, site activation, enrollment, conduct, monitoring, closeout, and inspection-readiness activities for assigned trials 
• Support planning and conducting investigator meetings in alignment with Director guidance
• Responsible for monitoring oversight, inclusive of study specific templates and plans, reviewing monitoring reports for compliance to study protocols, regulations and ICF/GCP, tracking and managing monitoring report metrics.
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