Director, Clinical Compliance
Jade Biosciences is a clinical-stage biotechnology company dedicated to developing best-in-class therapies for patients living with autoimmune diseases. The company is seeking a Director of Clinical Compliance to join its Development Operations Operational Excellence team. This role is integral to ensuring that all clinical trials adhere to ICH-GCP guidelines, regulatory requirements, internal Standard Operating Procedures (SOPs), and quality standards. The position is available in San Francisco and Seattle.
The Director of Clinical Compliance will collaborate with internal and external stakeholders to maintain inspection readiness and operational quality across all clinical programs. Key responsibilities include serving as a GCP compliance advisor to study teams, analyzing compliance metrics and audit findings to identify risks and process improvements, and ensuring continuous inspection readiness. The role also involves supporting vendor oversight, monitoring activities, and managing non-compliance issues, including the development and implementation of corrective and preventive actions (CAPAs).
Candidates should possess a Bachelor's degree with at least 15 years, a Master's degree with at least 12 years, or a PhD with at least 8 years of related experience, including a minimum of 10 years in clinical compliance. A strong understanding of ICH-GCP guidelines, regulatory requirements, and internal SOPs is essential. The ideal candidate will have experience in vendor oversight, monitoring, and audit support, as well as a proven track record in issue management and escalation.
While specific compensation details are not provided, Jade Biosciences offers a comprehensive benefits package, including health insurance, retirement plans, and other employee perks. The company is committed to fostering a collaborative and innovative work environment, providing opportunities for professional growth and development.
Joining Jade Biosciences offers the opportunity to be part of a dynamic team focused on transforming the future of autoimmune care. The company is dedicated to developing therapies that address critical unmet needs in autoimmune diseases, aiming to redefine the standard of care for patients.