Executive Director, Clinical Quality Assurance

About the role

Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies for autoimmune diseases. Our lead candidate, JADE101, targets the cytokine APRIL and is currently in a Phase 1 clinical trial for immunoglobulin A nephropathy. We also have JADE201, an afucosylated anti-BAFF-R monoclonal antibody, and JADE301, an undisclosed antibody candidate, in preclinical development. Jade was launched based on assets licensed from Paragon Therapeutics.

Responsibilities

• Provide hands-on clinical QA oversight and review of protocols, ICFs, CSRs, and other clinical trial-specific documents.
• Coach, make quality decisions, and serve as the Quality Approver for protocol deviations, vendor oversight, CAPAs, and issue management.
• Represent Quality on project teams, service providers, and CROs' operational meetings, and QA to QA meetings.
• Oversee ongoing clinical programs to ensure they are risk-based, fit-for-purpose, and compliant with applicable regulations and guidelines across all phases of development.
• Develop, implement, and execute a risk-based audit strategy and detailed plans for clinical and non-clinical studies.
• Establish and maintain GCP/GPvP/GLP QA programs, policies, and procedures.
• Lead the identification, investigation (root cause analysis), and resolution of quality issues through a robust investigation and CAPA process.
• Contribute to building a strong quality culture within the organization.
• Ensure the timely and effective follow-up of all identified or assigned quality issues.
• Direct and/or deliver yearly training for internal staff as needed.
• Work closely with Development, Clinical Operations, and other functions/departments to drive inspection readiness and support regulatory interactions.
• Champion continuous improvement and simplification across clinical quality systems.
• Prepare KPIs, metrics, and analysis and present status updates as needed.
• Provide leadership in inspection preparedness to clinical sites and service providers for regulatory government agencies.
• Stay current on global regulations, industry trends, and best practices to ensure continuous improvement and innovation within the QA function.
• Apply risk-based thinking to identify the quality activities that meaningfully influence study outcomes, rather than defaulting to checklists or bureaucracy.
• Provide clear, concise guidance that helps teams stay focused, aligned, and inspection ready.

Qualifications

• Bachelor's + 17 years, Master's + 15 years, or PhD + 10 years of related experience.
• Extensive expertise in GCP, GPvP, GLP, and ICH clinical requirements, clinical development, and methodologies of clinical studies.
• Successful track record of translating and implementing clinical requirements into operational execution.
• Extensive knowledge of FDA regulations and practices, ICH guidance, and strong knowledge of global health authority regulations and practices.
• A successful track record of working with service providers and CROs.
• Ability to make timely and sound quality decisions when faced with complex clinical, compliance, technical, and regulatory considerations.
• Highly skilled in working with ambiguity and complexity.
• Ability to tactically and strategically execute the day-to-day operations to support clinical trials and clinical and non-clinical development activities.
• Knowledge of Quality Management Systems; experience in building, implementing, and managing quality systems in the pharmaceutical industry.
• Expertise in reviewing, revising, and writing Standard Operating Procedures (SOPs).
• Effective communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies.
• Strong organizational skills and the ability to participate effectively cross-functionally.
• A self-starter and a team player who thrives in a fast-paced dynamic team environment.
• Previous experience in successfully leading assigned activities within cross-functional teams.
• Proficiency in using SharePoint, Veeva, and Microsoft Office applications (MS Outlook, MS Word, MS Excel, MS PowerPoint).

Benefits

This is a remote role; periodic travel to team and company events is required. The anticipated salary range for candidates for this role is $265,000 - $300,000. The final salary offered will depend on several factors, including relevant years of experience, educational background, and geography.

Pay

The anticipated salary range for candidates for this role is $265,000 - $300,000. The final salary offered will depend on several factors, including relevant years of experience, educational background, and geography.

Schedule

This is a remote role; periodic travel to team and company events is required.