Director, Clinical Compliance. Job in Menlo Park WestCoast-Jobs

  • Job Reference: 381587677-2
  • Date Posted: 27 September 2021
  • Recruiter: Grail, Inc.
  • Location: Menlo Park, California
  • Salary: On Application
  • Sector: Healthcare & Medical
  • Job Type: Permanent

Job Description

GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit .

The Director of Clinical Compliance will ensure the ethical and compliant conduct of GRAIL's global clinical studies. The Director will lead all aspects of GCP audits, ensuring regulatory inspection readiness, implementing GCP principles across diverse functional groups, managing clinical issues, and ensuring clinical trial related-SOP compliance.
You will:
  • Build, lead and provide strategic and operational leadership of the global clinical compliance function
  • Support the development and implementation of risk assessment and mitigation processes across global clinical trials
  • Ensure GCP principles and applicable clinical study requirements are understood, applied, and implemented across global clinical studies
  • Help manage GCP audits of clinical study sites, monitors, IRBs, CROs, and clinical data processes
  • Develop and implement a culture of continuous improvement, ensuring that clinical issues are appropriately managed and findings integrated into the clinical trial program
  • Responsible for readiness of the clinical trial program for health authority inspections
  • Manage and oversee GCP audits of clinical study sites, monitors, IRBs, vendors, and internal processes
  • Develop positive relationships with key partners throughout GRAIL
  • Ensure clinical trial-related SOPs are complete and updated with changes in law, regulation, policy or standards
  • Represent Clinical Compliance function across governance and strategic committees
  • Develop and promote a workplace culture that values diversity of thought, promotes integrity and builds an atmosphere that supports mentoring and fosters accountability
  • Provide data integrity guidance
  • Assist with establishing and implementing monitoring plans for clinical studies

Your background will include:
  • Specialist in FDA/ICH/GCP principles as it relates to clinical trial conduct. Medical Device experience desired.
  • Extensive sponsor support of health authority inspections and submission of marketing authorizations
  • Significant global clinical trial expertise and a successful track record of leading through influence, and working across complex global organizational matrices
  • Bachelor's degree required. Advanced degree preferred
  • At least 15 years of relevant industry experience, with substantial experience of managing staff in a global setting
  • Demonstrated partnership across various collaborative channels, such as, CROs, SMOs and/or local site networks
  • Technical expertise in clinical operations
  • Strong influential leadership and communication capabilities with a proven ability to engage, manage, develop and encourage a large, geographically diverse team

GRAIL is an Equal Employment Office and Affirmative Action 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 u s to request accommodation.

Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, GRAIL has made the decision to require all U.S. employees receive the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.

GRAIL, Inc. and its affiliates and subsidiaries ("GRAIL") does not accept any liability for fees for resumes from recruiters or employment agencies ("Agency"), without a binding, written recruitment agreement between GRAIL and Agency describing the services and specific job openings ("Agreement"). GRAIL may consider any candidate for whom an Agency has submitted an unsolicited resume and explicitly reserves the right to hire those candidate(s) without any financial obligation to the Agency, unless an Agreement is in place. Any email or verbal contacts with any person within GRAIL is inadequate to create a binding agreement. Agencies without an Agreement are requested not to contact any hiring managers of GRAIL with recruiting inquiries or resumes. Agencies interested in partnering with GRAIL may contact GRAIL's HR Department through our Customer Service team .