高级/临床试验经理

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 proventrack 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.

• Build effective working relationships with clinical sites, investigators, CROs, vendors, and internal stakeholders and serves as a key operational point of contact

• Review study performance metrics and operational data, identifies trends or gaps, and implements corrective and preventive actions in partnership with the Director and cross-functional team

• Ensure clinical trial activities and documentation comply with the protocol, Good Clinical Practice, applicable regulations, contractual requirements, and company procedures

• Support clinical supply, central laboratory, data management, safety, biostatistics, medical monitoring, and regulatory activities by coordinating operational requirements and timelines

• Oversee the maintenance of a complete, accurate, and inspection-ready Trial Master File documentation and supports audits, inspections, and quality oversight activities

• Mentor Clinical Trial Associates and Clinical Trial Managers; contributes to Clinical Operations process improvements, and prepare clear study updates for governance and senior leadership

Qualifications
· Bachelors and10+ years of related experience for Sr Clinical Trial Manager and 7+ years of related experience for the Clinical Trial Manager
· Trial management within a biopharmaceutical company; experience at a small startup is a plus.Demonstrated ability to manage complex clinical trial activities, timelines, vendors, budgets, risks, and cross-functional deliverables with appropriate independence and escalation 
· Experience supporting Phase 1 through Phase 3 clinical trials; global clinical trial experience is preferred 
· Immunology and/or rare disease clinical trial experience is preferred 
· Experience managing CROs and clinical vendors, including laboratories, RTSM, EDC, and ancillary clinical technology 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 overall drug development process

• Experience mentoring or providing day-to-day guidance to junior team members is preferred

• Excellent communication, organization, collaboration, problem-solving, and attention-to-detail skills, with the ability to manage competing priorities

Position Location
This is a remote role; periodic travel to team and company events is required.
The anticipated salary range for candidates for the Sr Clinical Trial Manager: $180,000 – 195,000, Clinical Trial Manger: $155,000 - $175,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography.

As part of the I-9 verification of authorization to work in the United States, Jade Bioscience participates in E-Verify. To learn more about E-Verify please review this poster.

Jade Biosciences is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

Originally posted on Himalayas