Director, Clinical Compliance
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AI Summary
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. For more information, visit JadeBiosciences.com and follow the Company on LinkedIn.
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
Monitoring Oversight
- Develop processes for oversight of monitoring activities conducted by CROs
- Review monitoring oversight plans, reports, and monitoring metrics
- Assess monitoring quality and compliance with monitoring plans
- Identify monitoring gaps and collaborate with study teams to address them
Non-Compliance Management
- Support identification and management of investigator or site non-compliance
- Assist study teams in evaluating protocol deviations and escalation needs
- Help develop remediation strategies for significant compliance issues
Issue Management and Escalation
- Support study teams in identifying and appropriately escalating significant compliance issues, protocol deviations, and site noncompliance, ensuring issues are investigated, documented, and resolved in accordance with regulatory expectations
- Drive and support development and implementation of CAPAs from audits, inspections, or compliance reviews
- Track CAPA effectiveness and ensure timely closure
- Identify recurring issues and support continuous improvement initiatives
Audit Support
- Partner with QA to support internal and external GCP audits
- Assist with audit preparation and documentation review
- Support study teams in addressing audit findings
Training & Compliance Education
- Provide training to clinical teams on ICH-GCP, regulatory requirements, and internal SOPs
- Identify knowledge gaps and support development of compliance training programs
- Contribute to SOPs, guidance documents, and best practice materials
Qualifications
- Bachelors + 15 years or Masters + 12 years or PhD + 8 years of related experience with 10+ years of relevant experience in biotech/pharma or CRO roles in Clinical Operations and/or Clinical Quality Assurance (GCP)
- Excellent communication, organizational, negotiation, and interpersonal skills with a strong reputation for collaboration
- Experience managing, coaching, and mentoring personnel
- Experience supporting global clinical trials in sponsor or CRO environments
- Strong working knowledge of ICH-GCP and global regulatory requirements
- Experience supporting GCP audits or regulatory inspections
- Experience with vendor oversight and CRO management
- Experience developing or implementing CAPAs
Position Location
This is a remote role; periodic travel to team and company events is required.
The anticipated salary range for candidates for this role is $210,000 - $235,000. 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.
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