GRAIL

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

Menlo Park, California, United States

Not SpecifiedCompensation
Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Healthcare, Biotechnology, DiagnosticsIndustries

Requirements

The Associate Director, Clinical Compliance must have a strong understanding of ICH E6 (GCP) and relevant diagnostic regulations, including CLIA and IVDR. Experience in leading inspection readiness and managing quality management systems is essential. The role requires the ability to identify compliance vulnerabilities, develop corrective action plans, and provide expert guidance on clinical and companion diagnostic regulatory standards and best practices.

Responsibilities

This role will lead and manage internal processes, clinical and diagnostic quality audits, and investigator site and service provider audits. Responsibilities include identifying compliance vulnerabilities, developing and driving corrective/preventive action plans, and tracking clinical compliance metrics. The Associate Director will provide routine clinical compliance support, lead risk assessment and mitigation strategies, and refine the organization’s inspection readiness framework. They will also serve as the primary point of contact for hosting inspections/audits, drafting responses, and leading post-inspection initiatives. Additionally, the role involves revising, developing, and maintaining procedures within the Clinical Quality Management System, and contributing to quality management policies and processes for clinical studies, LDTs, and companion diagnostic programs.

Skills

Clinical Compliance
GCP
CDx
Quality Management System
Audits
Risk Management
Regulatory Affairs
Clinical Studies
Leadership

GRAIL

Develops blood tests for early cancer detection

About GRAIL

GRAIL focuses on improving cancer detection through advanced blood tests that identify cancer at its earliest stages, enhancing treatment success rates. The company utilizes high-intensity sequencing to analyze tumor genome data, employing algorithms and deep learning to extract actionable information for early cancer detection. GRAIL differentiates itself from competitors by its commitment to large-scale clinical studies that validate the effectiveness of its tests. The primary goal is to reduce global cancer mortality by enabling early diagnosis, making the disease more treatable.

Menlo Park, CaliforniaHeadquarters
2016Year Founded
$1,765.5MTotal Funding
ACQUISITIONCompany Stage
Biotechnology, HealthcareIndustries
1,001-5,000Employees

Benefits

Outstanding People - Join a team of passionate and dedicated professionals, committed to collaboration, education, and proactive problem-solving.
Strong Compensation - We offer competitive salaries and savings plans to provide for long-term financial planning.
Complete Health Coverage - Take advantage of comprehensive health coverage, with medical, dental and vision, to keep you and your family healthy.
Work-Life Balance - Make everyday life more manageable with flexible time off – we trust you to do great work and take time for yourself.

Risks

Potential overdiagnosis could impact the perceived value of GRAIL's tests.
Significant net losses may affect investor confidence and long-term sustainability.
High test costs may limit accessibility in markets with less healthcare funding.

Differentiation

GRAIL uses high-intensity sequencing for early cancer detection via blood tests.
The Galleri test screens for over 50 cancers with a single blood draw.
GRAIL's tests are supported by large-scale clinical studies ensuring reliability.

Upsides

Collaborations with platforms like Function Health expand Galleri test accessibility.
Revenue from Galleri grew 52% year-over-year, indicating strong market demand.
GRAIL's technology aligns with trends in personalized and preventative medicine.

Land your dream remote job 3x faster with AI