Senior Staff Regulatory Affairs Associate # 4333

Job Description

Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care. We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges. GRAIL is headquartered in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit grail.com . 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.

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.

Preferred Qualifications:

• 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.
• Travel of up to 20%

The expected, full-time, annual base pay scale for this position is 142,000.00 - 178,000.00 Actual base pay will consider skills, experience, and location. Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time. In addition, GRAIL offers a progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings. GRAIL is an Equal Employment Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. GRAIL maintains a drug-free workplace. Apply for this job