Director, Clinical Compliance

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 in a Phase 1 clinical trial 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 undisclosed antibody candidate, both currently in preclinical development. Jade was launched based on assets licensed from Paragon Therapeutics, an antibody discovery engine founded by Fairmount.

Role Overview

The Director, Clinical Compliance collaborates with internal and external stakeholders to ensure that clinical trials conducted by Jade adhere to ICH-GCP, regulatory requirements, internal SOPs, and quality standards. Embedded within the Development Operations Operational Excellence team, this role functions as an internal GCP compliance leader who partners closely with study teams, vendors, and Quality Assurance (QA) to maintain inspection readiness and operational quality across all clinical programs. This individual will lead initiatives related to vendor oversight, monitoring oversight, compliance metrics and issue management and escalation, while serving as a key liaison between Clinical Operations and the GCP Quality organization during audits and regulatory inspections.

Key Responsibilities

Clinical Compliance Oversight

• Serve as a trusted GCP compliance advisor to all functions within study teams by promoting a culture of quality and helping teams integrate compliant practices into daily study execution and decision-making
• Analyze compliance metrics, audit findings, monitoring data, and operational trends across programs to identify systemic risks and opportunities for process improvement
• Apply risk-based judgment in interpreting and implementing GCP requirements, balancing regulatory expectations with operational realities to ensure compliance approaches are practical, defensible, and appropriate to the level of risk

Inspection Readiness

• Drive initiatives to ensure continuous inspection readiness across clinical studies
• Assist in preparation for regulatory inspections and internal audits including readiness assessments and document reviews
• Support development of inspection storyboards and response strategies when needed
• Ensure study teams maintain inspection-ready documentation and evidence of ongoing compliance

Vendor Oversight & KPI Monitoring

• Support oversight of CROs and other clinical vendors to ensure compliance with contractual and regulatory expectations
• Partner with Development Outsourcing on defining and tracking vendor performance metrics and KPIs
• Participate in vendor governance meetings and performance reviews
• Identify trends or risks in vendor performance and recommend mitigation strategies
• Review and track vendor QEs