Full-Time

Associate Director Clinical Compliance

Multiple Teams

Posted on 9/15/2025

GRAIL

GRAIL

1,001-5,000 employees

Blood-based cancer detection via sequencing tests

Compensation Overview

$164k - $205k/yr

+ Annual Bonus + Incentive Plan + Long-term Incentive Plan

Menlo Park, CA, USA

Hybrid

Hybrid position requiring some in-office presence.

Category
Medical, Clinical & Veterinary (1)
Required Skills
Risk Management
Google Cloud Platform
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.
Desired 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.

GRAIL develops blood-based cancer tests that aim to detect cancer at its earliest stages. The tests use high-intensity sequencing to analyze large amounts of tumor genome data from a blood sample and apply advanced algorithms and deep learning to identify signals indicating cancer. Revenue comes from selling these tests to healthcare providers and research institutions, with potential expansion to direct-to-consumer sales in the future. Compared with others, GRAIL combines extensive sequencing data with clinical studies and sophisticated analytics to provide actionable cancer-detection results, focusing on early diagnosis. The company’s goal is to lower global cancer mortality by catching the disease early when treatment is more effective.

Company Size

1,001-5,000

Company Stage

Post IPO Equity

Headquarters

Menlo Park, California

Founded

2016

Simplify Jobs

Simplify's Take

What believers are saying

  • Galleri test volumes surged 50% YoY to 56,000 in Q1 2026.
  • Epic integration enables direct physician ordering by year-end 2026.
  • PATHFINDER 2 study detected 40.4% cancers, half at early stages.

What critics are saying

  • NHS trial failed primary endpoint, shares crashed 50% February 2026.
  • FDA rejects Galleri PMA due to observational PATHFINDER 2 data.
  • American Cancer Society blocks reimbursements without further research.

What makes GRAIL unique

  • Galleri detects over 50 cancers via blood DNA methylation patterns.
  • Predicts cancer origin with 93.4% accuracy from single blood draw.
  • DHA approved for TRICARE patients 50+ with elevated cancer risk.

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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.

Growth & Insights and Company News

Headcount

6 month growth

-1%

1 year growth

-1%

2 year growth

0%
PR Newswire
Apr 10th, 2026
Junction partners with GRAIL to enable multi-cancer screening through diagnostic platform

Junction, a diagnostic testing infrastructure platform, has announced a collaboration with GRAIL to support access to the Galleri multi-cancer early detection test across digital health platforms and clinical organisations. Through Junction's infrastructure, healthcare providers can integrate Galleri into their workflows with unified ordering, embedded physician networks and streamlined operational support. The Galleri test is a blood test designed to detect signals from over 50 cancer types, many lacking recommended screening options. Junction's platform enables organisations to order the Galleri test directly, support multi-state clinical operations and manage complex testing workflows. The collaboration aims to simplify the operational steps around offering Galleri, making it easier for providers to integrate the test into care delivery. Junction provides infrastructure that powers healthcare platforms through a single API.

360Dx
Apr 7th, 2026
Grail, Epic partner to broaden Galleri MCED test ordering.

Grail, Epic partner to broaden Galleri MCED test ordering. NEW YORK - Grail on Tuesday announced a collaboration with Epic to integrate the Galleri multi-cancer early detection test into Epic's electronic health record platforms. Get the full story with 360dx Premium. Only $95 for the first 90 days. Full site access Interest-based email alerts Premium Access - Trial Offer $95.00 for 3 month

Yahoo Finance
Mar 22nd, 2026
One Fin exits $22M GRAIL stake before 50% crash

One Fin Capital Management completely exited its position in GRAIL on 17 February 2026, selling approximately 380,000 shares worth $22.47 million. The timing proved fortuitous, as GRAIL subsequently experienced a roughly 50% single-day decline following an earnings announcement. The liquidation reduced GRAIL's weighting in the fund's portfolio from 7.4% to zero. GRAIL, a biotechnology company specialising in blood-based multi-cancer early detection, had been a strong performer with shares up 68% year-to-date prior to the crash. Despite selling over 185,000 Galleri tests and generating $147.2 million in revenue, GRAIL reported a net loss of $408.35 million. The company's current market capitalisation stands at $1.9 billion.

Clinical Research News
Mar 19th, 2026
ClearNote Health appoints Jeffrey Venstrom, MD, as chief medical officer and expands leadership team to drive clinical adoption of early cancer detection tests.

ClearNote Health appoints Jeffrey Venstrom, MD, as chief medical officer and expands leadership team to drive clinical adoption of early cancer detection tests. Mar 19, 2026, 07:46 AM by The team at ClearNote Health strengthened its leadership team with four key additions. Daniel Black named general manager of international markets; Irene Hsieh named vice president of regulatory affairs and quality assurance; Jeremy Bennett named head of marketing SAN DIEGO - March 18, 2026 - ClearNote Health, a company focused on improving early detection for some of the deadliest cancers, today announced four strategic additions to its executive leadership team: Jeffrey Venstrom, MD, as chief medical officer; Daniel Black, DBA, as general manager of international markets; Irene Hsieh as vice president of regulatory affairs and quality assurance; and Jeremy Bennett as head of marketing. These appointments mark a significant milestone as the company expands clinical validation, advances regulatory pathways, and drives broader global commercial adoption of its proprietary early cancer detection tests and epigenomic drug development platform. "We're building a leadership team with the experience and vision required to transform early cancer detection at a global scale," said Dave Mullarkey, CEO of ClearNote Health. "Jeff, Daniel, Irene, and Jeremy bring a proven track record of scaling innovative healthcare organizations and translating breakthrough science into real-world clinical impact. Their leadership will help accelerate adoption of our technology, expand our clinical reach, and give more patients the opportunity to detect cancer earlier, when treatment options and outcomes are greatest." Strengthening Clinical Leadership As chief medical officer, Dr. Venstrom will lead clinical development, medical affairs, and real-world evidence generation for early cancer detection. A physician-scientist with deep expertise in oncology, hematology, and drug and diagnostic development, he brings decades of leadership across academic medicine and global biopharma. Prior to joining ClearNote Health, Dr. Venstrom served as the global head of diagnostics for Eli Lilly and Company and the chief medical officer at Grail. Prior to that, he spent eight years at Roche / Genentech, including two years as head of clinical development and medical affairs at Foundation Medicine. Earlier in his career, he held the Krishnamurthi Endowed Chair in Hematologic Malignancies at the University of California, San Francisco, where he provided clinical care for cancer patients and served as principal investigator for several industry-sponsored translational research trials and collaborations. Dr. Venstrom completed his clinical oncology and cancer immunology research training at Memorial Sloan-Kettering Cancer Center in New York and his internal medicine training at The Johns Hopkins Hospital. He earned his medical and bachelor's degrees from Vanderbilt University and received additional research training at the National Institutes of Health. "Early detection of cancer for high-risk patients represents one of the largest unmet needs in healthcare," said Dr. Venstrom. "Due to their remarkable sensitivity and specificity, ClearNote Health's blood-based tests have the potential to fundamentally shift oncology from late-stage intervention to proactive early detection. I am excited to work with leading clinicians, health systems, and researchers to generate the rigorous evidence required to establish our tests as new standards of care." Advancing Regulatory and Quality Excellence Ms. Hsieh's promotion to vice president of regulatory affairs and quality assurance comes at a pivotal time as ClearNote Health advances discussions with regulatory authorities and prepares for expanded clinical studies. In her new role, she will lead regulatory submissions, quality oversight, and cross-functional alignment to ensure the company's platform meets the highest clinical and regulatory standards. Ms. Hsieh has more than 17 years of experience in global regulatory strategy, quality systems implementation, and compliance in complex diagnostic environments at leading diagnostics and pharmaceutical organizations, including Revvity, ChromaCode, Thermo Fisher Scientific, Shire, and Abbott. Ms. Hsieh earned a bachelor of science degree from the University of California, San Diego, and a master of science degree from San Diego State University. Accelerating Global Commercial Adoption Dr. Black joins ClearNote Health as general manager of international markets, bringing a successful history of scaling innovative diagnostics and biotech solutions from early-stage development to international market adoption. He will oversee global go-to-market strategy, business development, partnership management, and market access initiatives to accelerate the commercial expansion of ClearNote Health's epigenetic-based early cancer detection portfolio. He has 20 years of experience in international commercial leadership across the biotech and medtech sectors, having held senior roles at Centogene and Roche Diagnostics, with increasing responsibility across global marketing, product management, and strategic partnerships. Dr. Black earned a bachelor of science degree and a master of business administration degree from the Graduate School Rhein-Neckar in Mannheim, Germany, along with a doctor of business administration from Warsaw Management University in Warsaw, Poland. Mr. Bennett joins ClearNote Health as head of marketing, bringing a track record of scaling innovative healthcare technologies from early commercialization to international adoption. He will oversee brand strategy, go-to-market execution, provider engagement, and patient education initiatives. Previously, Mr. Bennett was the vice president of marketing at iCAD, a global leader in AI-powered breast health solutions. Prior to that, he spent more than 16 years at Myriad Genetics, serving in senior marketing positions across imaging, oncology, and women's health. Mr. Bennett earned a bachelor of science degree from the Pennsylvania State University and a master of science degree from the University of Utah. ClearNote Health's leadership expansion occurs as the company builds on the recent success of its enhanced Avantect(R) Pancreatic Cancer Test. Designed as a simple blood-based test, the ClearNote Avantect tests are intended for patients at elevated risk of cancer. They feature an integrated, multianalyte, multiomic approach with optimized machine learning algorithms. With the high overall cancer detection sensitivity and specificity, the Avantect tests help clinicians to identify early-stage cancers sooner, enabling more informed and timely clinical management decisions.[1] About ClearNote Health ClearNote Health is a privately held company dedicated to improving early detection and monitoring for some of the deadliest forms of cancer. Developed by scientists in the Stephen Quake laboratory at Stanford University, the company's patented core Virtuoso(TM) epigenomics platform builds on the latest advances in artificial intelligence and bioinformatics to measure active biological differences between cancer and healthy cells in a blood sample. Its highly sensitive, noninvasive Avantect(R) pancreatic and ovarian tests may identify cancers in high-risk patient populations earlier than conventional approaches, when patients may be more likely to benefit from treatment. The company's multi-cancer detection test was recently selected as one of two blood-based technologies for the National Cancer Institute's Vanguard Study. ClearNote Health's headquarters and CLIA-certified, CAP-accredited and New York State Department of Health-approved laboratory are located in San Diego. For more information, visit www.clearnotehealth.com or follow the company on LinkedIn. References [1] Data on file ClearNote Health, the ClearNote Health logo, and Avantect are registered trademarks of ClearNote Health. The Avantect Test has not been cleared or approved by the U.S. Food and Drug Administration.

Endpoints News
Mar 13th, 2026
Grail names new CEO as Bob Ragusa retires

Grail names new CEO as Bob Ragusa retires. Features editor. Grail on Thursday announced that its CEO, Bob Ragusa, will retire and is handing the reins to its current president Josh Ofman. The cancer screening... Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.

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