Director, Clinical Compliance

🔥 0 minutes ago

🏄 California, Washington – Remote

🏄 California – Remote ☕ Washington – Remote

💵 $210k - $235k / year

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

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Jade Biosciences

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2024

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

Jade Biosciences is a clinical-stage biotechnology company developing potentially best-in-class therapies aimed at transforming the standard of care for autoimmune diseases. Its lead candidate, JADE101, is an antibody designed to inhibit the cytokine APRIL (A PRoliferation-Inducing Ligand) and is being developed for the treatment of immunoglobulin A nephropathy (IgAN). The company builds its pipeline from discovery-stage assets licensed from Paragon Therapeutics and is focused on advancing clinical programs to deliver new treatments for patients with autoimmune conditions.

📋 Description

• 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 • 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 • 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 • 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 • 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 • 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 • Partner with QA to support internal and external GCP audits • Assist with audit preparation and documentation review • Support study teams in addressing audit findings • 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.

🎯 Requirements

• 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.