Teams at Jade Biosciences, Inc.

Lead GCP compliance for clinical programs: oversee vendor and monitoring oversight, drive inspection readiness, analyze compliance metrics, manage non-compliance and CAPAs, support audits, and deliver training to ensure trials meet ICH-GCP, regulatory, and internal quality standards.

Field-based clinical partner responsible for site engagement, protocol support, enrollment accountability, and cross-functional coordination to drive consistent trial execution and provide regional site insights to support global enrollment.

Lead regulatory strategy and execution for biologics development, preparing and submitting INDs/CTAs and other health authority filings. Draft, review, and manage regulatory documents and responses, ensure compliance with global regulations (FDA, ICH, GCP, GMP), identify regulatory risks, and provide regulatory input to clinical study planning.