GRAIL

Director

• Interface with individuals at all levels of the organization to conduct audits at specified intervals and report audit findings
• Facilitate and monitor the life-cycle of audit findings until completion
• Promote continuous improvement of systems, products, and services
• Establish and maintain QMS systems that are in conformance with international and local requirements
• Develop, manage and execute inspection readiness programs across the GRAIL QMS to ensure site readiness at all times
• Manage and support the external regulatory compliance inspections (CAP, NYSDOH, FDA, IVDR)
• Provide guidance to assist in the development, implementation, and maintenance of the Quality Management Systems
• Develops and provides inspection execution related training in support of compliance systems and quality improvements
• Partners with various internal and external groups to help analyze problems
• Develops and creates audit reports, coordinates action plans, and follow-up with auditee to assure prompt and adequate completion of agreed upon actions
• Establishes and conducts sectional readiness training for GRAIL functions
• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors
• Directly responsible for ongoing maintenance and continuous improvement of this audit program
• Coaches/mentors staff as a means to ensure performance and professional development

Director, Quality Audits

Customer Support

• Lead the development and implementation of new customer service programs, tools, and initiatives from concept through completion
• Act as the primary point of contact for internal stakeholders on all customer service operational initiatives
• Analyze performance data to identify pain points, trends, and opportunities for improvement
• Build reporting frameworks and dashboards to monitor key performance indicators
• Prepare reports for upper management or other departments, including production statistics and forecasting projections
• Optimize and document workflows to improve efficiency, scalability, and quality of service
• Develop and refine standard operating procedures (SOPs) for customer service operations
• Ensure readiness and alignment across teams for new launches, process updates, and operational changes
• Research best practices, tools, and emerging trends in customer service operations
• Identify and test new models or technologies to enhance team performance and the customer experience

Customer Service Operations Lead

Consultant

• Be part of a best-in-class commercial organization
• Report directly to a GRAIL District Manager
• Prospect and target primary care practices in your territory to generate interest in Galleri and identify/onboard early adopter customers
• Represent a diverse team of professionals to enhance our competitiveness and innovation
• Work with executive sales leadership, marketing, customer service, billing, and other customer-facing functions to provide “on the ground” feedback that will help shape our strategies and execution plans
• Develop and implement a business plan to support your territory’s growth
• Demonstrate and leverage a deep understanding of the Laboratory Developed Test (LDT) market, competitive landscape and current cancer screening options, in the effective execution of sales activities and growth
• Meet or exceed sales goals by increasing breadth and depth of prescribing, maximize the impact of promotional budgets, and execute the national sales strategy in accordance with GRAIL standards and management expectations.
• Identify opportunities in the marketplace, share best practices, and proactively communicate successful selling strategies to peers, management, cross-functional partners, and members of the Commercial Team Manage implementation of all promotional activities to support sales and marketing strategies, in accordance with high industry standards and company policies
• Collaborate with Medical Science Liaisons (MSLs) to educate providers on the science and studies that support MCED technology, and build relationships with Key Opinion Leaders.

GRAIL Galleri Consultant

Sales

• Engage physicians and their staff to think differently about cancer screening
• Integrate MCED technology into office workflow
• Make in-person visits to targeted physician practices
• Plan and support events
• Execute on Company initiatives
• Prospect and target primary care practices to generate interest in Galleri
• Collaborate with executive sales leadership, marketing, customer service, and other customer-facing functions

Clinical Sales Consultant

• Lead the development and implementation of new customer service programs, tools, and initiatives from concept through completion.
• Act as the primary point of contact for internal stakeholders on all customer service operational initiatives.
• Analyze performance data to identify pain points, trends, and opportunities for improvement.
• Build reporting frameworks and dashboards to monitor key performance indicators. Prepare reports for upper management or other departments, including production statistics and forecasting projections.
• Optimize and document workflows to improve efficiency, scalability, and quality of service.
• Develop and refine standard operating procedures (SOPs) for customer service operations.
• Ensure readiness and alignment across teams for new launches, process updates, and operational changes.
• Research best practices, tools, and emerging trends in customer service operations.
• Identify and test new models or technologies to enhance team performance and the customer experience.

Clinical Research

• Serves as the Clinical Operations Study Lead for assigned studies, providing strategic and operational leadership to ensure successful planning, execution, and delivery of clinical studies.
• Supports and guides Clinical Trial Managers and Clinical Project Assistants ensuring alignment of study activities, promoting best practices, and driving a unified approach to achieve study objectives.
• Acts as the primary point of contact for internal cross functional teams.
• Leads site management and performance oversight, including ensuring proper training, fostering strong site relationships, and monitoring compliance with study protocols, plans, SOPs, GCP/ICH, and all applicable regulatory requirements.
• Manages all clinical operational aspects of a clinical trial from site selection, start-up, enrollment, maintenance, and close-out.
• Develops study related plans and documents, including informed consent forms, ensuring alignment with study objectives, regulatory requirements, and overall study strategy.
• Collaborates on site identification and selection.
• Participates in EDC set-up by contributing to case report form design, user acceptance testing, development of completion guidelines, and other related activities, supporting study requirements and data quality.
• Oversees clinical data entry progress ensuring timely resolution of incomplete data and outstanding queries.
• Contributes to the development and management of site budgets and ensures timely and accurate invoice payments in accordance with site payment terms.
• Partners with cross functional stakeholders such as Clinical Data Management, Biospecimen Management, Finance, Clinical Compliance, Clinical Science, and Lab Operations to define study strategy, align operational plans, and proactively identify and mitigate risks to ensure successful execution.
• Provides oversight of regional study monitors and/or contract research organizations (CRO) to ensure quality, compliance, and timely study execution while proactively addressing risk and performance issues.
• Facilitate external communication with site staff and pharmaceutical partners (as applicable).
• Ensures electronic Trial Master File (eTMF) is current and maintained.

Senior Clinical Trial Manager

Compliance

• Strategize, scope and plan regulatory activities to best position GRAIL’s products with FDA and/or health authorities
• Lead and guide IVD submission teams on strategies to realize cross-functional efﬁciencies throughout the organization.
• Directly responsible for authoring and providing critical input on FDA/Health Authority submissions for GRAIL MCED products including PMA modules, IDEs, annual reports/supplements, Study Risk Determinations and pre-submissions etc.
• Lead regulatory contact for FDA, Health Authority negotiations on GRAIL MCED products.
• Provide project portfolio headcount and budgeting approximations to the Project Team; attend project team meetings, as needed, to assign resources and provide regulatory input.
• Serve as a key member of the Regulatory team providing insights, solutions and direction on general business and product portfolio matters.
• Provide regulatory support towards new and currently marketed products including both IVDs and Lab Developed Tests, e.g., labeling, promotional material, product changes and documentation for compliance and for changes requiring regulatory agency approval.
• Review, interpret, and report to Regulatory and Business leadership on product speciﬁc regulatory issues that may have material impact on the business or the customer.
• Work with Regulatory Affairs leadership to develop strategic and tactical responses to inﬂuence a reasonable regulatory environment.
• Acquire and maintain current knowledge of applicable regulatory requirements and scientific and technical issues in the geographic and subject area as relevant to assigned projects.
• Lead the identiﬁcation of regulatory risk areas and develop alternative courses of action.
• Assess impact of new regulations and work with cross-functional partners to implement appropriate changes.
• Represent GRAIL during communication and meeting with FDA, Health Authorities and work with regulatory authorities on regulatory and technical matters, as appropriate.
• Support the Compliance Team with respect to healthcare laws relevant to medical devices and laboratory operations (e.g., CLIA, HIPAA).
• Ensure compliance with regulations and laws pertaining to the GRAIL business and provide guidance and advice.
• Independently review and approve Regulatory Strategy Documents, Regulatory Plans, procedures, SOPs and other documentation with respect to commitments, regulations and ﬁlings.
• Support the development and review of Standard Operating Procedures and policy guidelines for the regulatory affairs department.
• Provide consultative and training support to the business teams and core regulatory personnel related to premarket submissions, product labeling, and complex submissions issues
• This position may have direct reports in the future which includes, but is not limited to, employment decisions, selection, performance feedback, pay decisions, and handling employee’s grievances/complaints.
• Perform other duties as required or assigned

Regulatory Affairs Director

• Lead strategy, goal setting, forecasting, and execution of payer coverage programs to expand opportunities, positioning GRAIL as a high-value partner in early cancer detection.
• Develop market- and partner-specific value propositions by deeply understanding business objectives and strategic priorities, influencing the design of both short- and long-term goals for high-functioning partnerships.
• Lead and manage a cross-functional team of market access professionals, providing strategic direction, performance management, and professional development.
• Oversee day-to-day operations and ensure alignment with corporate goals across pricing, reimbursement, payer strategy, and patient access functions.
• Serve as the subject matter expert in coverage, coding, and reimbursement strategies for GRAIL products.
• Own gap analysis and cross-functional readiness planning for coverage milestones. Mobilize teams across the organization to maximize access at those milestones.
• Develop and execute pricing strategies for GRAIL product lines that align with short- and long-term objectives.
• Mobilize cross-functional teams across GRAIL to drive key initiatives in policy, evidence development, and payer engagement.
• Negotiate complex contracts, establish and lead quarterly senior executive meetings, and develop partnership opportunities, collaborating with medical and clinical development teams when evidence generation is required.
• Anticipate and address partner needs across the system of care.
• Ensure compliant access to GRAIL products.

Senior Director, Market Access

• 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

• 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

• 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.

Inside Sales Representative, Enterprise Channel

• 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

• 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

• 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?