Associate Director Clinical Compliance # 4333 (Menlo Park, CA)

GRAIL • Menlo Park, CA

99d • $164,000 - $205,000

About The Position

Grail’s Clinical Compliance department is seeking a compliance expert to support compliant conduct of Grail’s clinical studies and to support Grail's partnerships with pharmaceutical companies for companion diagnostic (CDx) tests. The Associate Director, Clinical Compliance will play a key leadership role in shaping and strengthening Grail’s Clinical Quality Management System (CQMS) and advancing clinical compliance oversight across clinical studies and companion diagnostic (CDx) development. In this highly visible role, you’ll collaborate cross-functionally to proactively manage both GCP and CDx regulatory risks, lead inspection readiness, and continuously improve quality standards utilizing insights from inspections, audits, and evolving regulatory landscapes.

Requirements

• Bachelor’s degree or higher in a scientific, health, quality, or regulatory discipline (advanced degree preferred).
• 10 + years relevant experience in clinical quality assurance, diagnostics, and/or regulatory compliance within the diagnostics, or medical device field.
• Experience supporting regulatory inspections such as BIMO. Demonstrated experience managing GCP and/or CDx inspection and audit preparation and response.
• Expert knowledge of applicable regulations and standards as they relate to clinical trial conduct.
• Understanding of appropriate global medical device/IVD requirements, such as: ICH E6 (GCP), European Union (ISO 20916, ISO 14155, IVDD/IVDR), US [21 CFR Part 812 and Part 11].
• Experience managing GCP quality processes such as managing Quality Events and CAPAs; and participating in risk management activities.
• Conducting GCP audits of internal processes, clinical investigator sites, and clinical service vendors.
• Demonstrated ability to initiate process improvements and take initiative.
• Strong influencing skills, with the ability to work collaboratively and cross functionally, within a constantly evolving fast-paced startup environment.
• Ability to drive and manage change with a positive approach.

Responsibilities

• Lead and manage internal processes and systems, clinical and diagnostic quality audits, as well as investigator sites and service provider audits and gap assessments.
• Identify areas of compliance vulnerability in both clinical and CDx pipelines, develop and drive corrective/preventive action plans, and track clinical compliance-related metrics for senior leadership.
• Provide routine clinical compliance support to clinical study, and CDx project teams, ensuring adherence to ICH E6 (GCP), relevant diagnostic regulations, and internal quality standards.
• Support and, where necessary, lead risk assessment and mitigation strategies for clinical studies and CDx programs.
• Lead and continuously refine the organization’s inspection readiness framework for clinical studies and companion diagnostic development, spanning global and regional regulatory inspections (e.g., BIMO, pre-approval, GCP, CLIA, IVDR).
• Conduct inspection readiness training and coaching sessions.
• Serve as the primary point of contact for hosting inspections/audits, drafting and tracking responses to findings, driving resolution, and leading post-inspection lessons-learned initiatives.
• Revise, develop, and maintain procedures within the Clinical Quality Management System, leveraging lessons from inspections, audits, and emerging clinical compliance trends, in both GCP and CDx domains.
• Contribute to, implement, and continuously improve quality management policies and processes related to clinical studies, laboratory-developed tests, and companion diagnostic programs.
• Own and maintain GCP audit program SOPs and templates, ensuring they remain current with evolving regulatory requirements and industry best practices.
• Review and provide compliance advice on SOPs, processes, and protocols for both clinical trial and companion diagnostic activities, ensuring consistency and compliance with relevant GCP, CLIA, FDA/IVDR, and other global diagnostic regulatory requirements.
• Serve as a resource and subject matter expert on clinical and companion diagnostic regulatory standards and best practices.
• Provide leadership, expertise, and guidance in clinical and companion diagnostic compliance to internal and external stakeholders.
• Promote a culture of quality and clinical compliance, proactively identifying compliance risks and embedding best practices into organizational processes.
• Collaborate with cross-functional teams (e.g., Regulatory, Quality Assurance, Lab Operations, Clinical Data Management, etc.), and senior leaders to establish inspection norms and foster continuous improvement.

Benefits

• Flexible time-off
• 401k with a company match
• Medical, dental, vision plans
• Mindfulness offerings

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees