GRAIL

Compliance

• Lead and manage internal processes and systems, clinical and diagnostic quality audits, investigator sites and service provider audits, and gap assessments
• Identify areas of compliance vulnerability in clinical and CDx pipelines and develop/drive corrective and preventive action plans
• 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 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 across global and regional regulatory inspections (BIMO, pre-approval, GCP, CLIA, IVDR)
• Conduct inspection readiness training and coaching sessions
• Serve as 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 compliance trends
• 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
• Review and provide compliance advice on SOPs, processes, and protocols for clinical trial and companion diagnostic activities to ensure consistency with GCP, CLIA, FDA/IVDR, and other global diagnostic regulatory requirements
• Serve as subject matter expert and provide leadership, expertise, and guidance in clinical and companion diagnostic compliance to internal and external stakeholders
• Promote a culture of quality and clinical compliance and collaborate with cross-functional teams and senior leaders to establish inspection norms and foster continuous improvement

Associate Director, Clinical Compliance

Clinical Research

• Conceptualization, design, implementation and analysis of clinical evidence generation studies
• Lead cross-functional teams on design, conduct and analysis of clinical studies with academic, community, and industry partners
• Design and implement approaches to review, clean, analyze and integrate large and complex clinical datasets
• Lead regular and ad-hoc data reviews and interpretation of clinical data; prepare and present summaries/documentations
• Oversee data quality review activities and resolve data quality issues
• Lead strategic efforts to advance clinical development and scientific plans; engage key opinion leaders; provide expert scientific input
• Contribute to development of data collection forms and data/metadata standards
• Collaborate with Biostatistics to develop statistical analysis plans and co-author clinical study reports
• Represent Clinical Science as thought leader on cross-functional teams
• Ensure data integrity and quality, appropriate blinding and data privacy standards
• Develop electronic case report forms and other clinical data capture methods
• Lead development of study reports, presentations, and publications
• Conduct literature reviews and obtain external data (e.g., SEER, US Census) to inform or interpret study results
• Develop formal networks with external investigators and thought leaders
• Ensure compliance with industry regulations, policies, guidelines and standards

Senior Principal Clinical Research Scientist

Software Engineer

• Supervise day-to-day activities of Tier 2 support staff of junior engineers across second shift operations.
• Provide hands-on troubleshooting and support for laboratory instrumentation, automation platforms, and software applications to minimize downtime.
• Monitor system health and performance, coordinate corrective actions, and escalate complex issues to Tier 3 or engineering leads as needed.
• Facilitate Post-Incident Reviews: root-cause analysis, corrective/preventive actions (CAPA), and risk assessment; track action items and report weekly metrics.
• Facilitate end-to-end automated line-swap task plans, including task detailing, pre-swap risk reviews, resource coordination, and on-shift execution oversight.
• Coordinate maintenance and calibration activities in alignment with established protocols and the Enterprise Asset Management (EAM) / Computerized Maintenance Management System (CMMS).
• Document service incidents, troubleshooting activities, and repairs in accordance with quality management system (QMS) and cGMP/GLP requirements.
• Train and mentor team members on technical procedures, safety practices (LOTO, hazardous material handling), and SOP adherence.
• Support continuous improvement efforts by identifying opportunities for process and equipment optimization.
• Assist with inventory oversight for spare parts, consumables, and support contract coordination.
• Collaborate with cross-functional partners including Quality, R&D, and Software to support change implementation and validation testing.
• Participate in on-call duty and support weekends and holidays as needed.

Supervisor, Engineering Operations

• Support overall day-to-day execution of clinical trials, including site selection, start-up, enrollment, maintenance, and close-out.
• Prepare and review study-related plans and documents including protocols, informed consent forms, recruitment plans, monitoring plans, protocol deviation plans, and case report forms.
• Identify, select, and monitor performance of clinical sites; ensure site training and compliance with study plans, SOPs, FDA regulations, ICH/GCP.
• Participate in EDC setup, case report form design, user acceptance testing, and related activities.
• Identify risks to study timelines/conduct, propose and implement mitigations with cross-functional team support.
• Monitor clinical data entry progress and follow up on incomplete data and queries.
• Contribute to development and management of site budgets and ensure invoice payment.
• Work cross-functionally with Legal, Clinical Data Management, Biospecimen Management, Finance, Clinical Compliance, Clinical Development, and Lab Operations.
• Provide oversight of regional study monitors and/or CROs; facilitate external communication with site staff and pharmaceutical partners.
• Ensure Trial Master File (TMF) is current and maintained; provide guidance and mentorship to Clinical Project Assistants (CPAs).

Clinical Trial Manager

Account Executive

• Enterprise Inside Sales Associate to open doors and build new relationships with self-insured employers, payers and first responders in an assigned territory
• Identify companies and contacts for outreach, secure meetings with key decision-makers, and manage a robust pipeline of marketing qualified leads
• Work in collaboration with the Enterprise (Employer, Health Plan, Life Insurance and first responders) and Marketing teams and report to the Associate Director of Inside Sales
• This role is a great “foot in the door” opportunity for a lucrative career in B2B/enterprise sales

Inside Sales Representative, Enterprise Channel

• Grail seeks a highly motivated, self-starter Enterprise Inside Sales Associate to open doors and build new relationships with self-insured employers, life insurers, payers and first responders in an assigned territory. You will identify companies and contacts for outreach, secure meetings with key decision-makers, and manage a robust pipeline of marketing qualified leads. This role will work in collaboration with the Enterprise (Employer, Health Plan, Life Insurance and first responders) and Marketing teams and report to the Associate Director of Inside Sales. This role is a great “foot in the door” opportunity for a lucrative career in B2B/enterprise sales.

• 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.
• For more information, please visit grail.com.
• The role assists with regulatory strategy and the development of submissions in partnership with key internal and external stakeholders for GRAIL projects, including Multi-Cancer Early Detection (MCED).
• The position supports the U.S. Regulatory team in preparing Investigational Device Exemptions (IDEs), IDE supplements, pre-submissions, Premarket Approvals (PMAs), annual reports, and other relevant documentation.
• The role collaborates cross-functionally with Quality, Lab Operations, and other stakeholders to support regulatory strategy development, product validation, audits, promotional material review, on-market product support, and change control processes.
• This individual monitors and communicates changes in regulatory policies and In Vitro Diagnostic (IVD) requirements to project teams and leadership. They may manage and provide direction to regulatory staff and, when required, participate in senior management meetings as a delegate.
• The role fosters a work culture aligned with GRAIL’s values

Regulatory Affairs Associate Director

Consultant

• Our mission is to detect cancer early, when it can be cured.
• We are a healthcare company pioneering new technologies to advance early cancer detection.
• GRAIL is headquartered in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom.
• For more information, please visit grail.com.
• This is a great opportunity to join the growing commercial team at GRAIL, as a GRAIL Galleri Consultant (GGC), working hand in hand with sales leadership and internal stakeholders to execute the go to market sales strategy for GRAILs revolutionary MCED (multi-cancer early detection) product Galleri.
• This is a customer-focused position that requires a “market builder” mindset. A successful GGC acts with urgency and passion to engage physicians and their staff to think differently about cancer screening and change the way they practice, integrating MCED technology into their office workflow, and consistently offering it to appropriate patients with the goal to identify more cancers sooner.
• GRAIL is the first company in the world to bring MCED technology to patients and clinicians - this is a rare opportunity in ones career! This position is field based and will oversee the Santa Monica Territory. 
• The GGC role is an in-person selling role, with the expectation that candidates spend the majority of their time (>85%) making in-person visits to targeted physician practices, planning and supporting events, and executing on Company initiatives.
• Candidates must reside within the territory in one of these locations- Santa Monica, Culver City, or surrounding areas.
• We’re building a world-class team to take on one of healthcare’s most important challenges. Are you ready to join us?