Director Clinical Quality (IDE, GCLP, and CLIA)

Company: Guardant Health
Location: San Diego
Posted on: February 22, 2021

Job Description:

Director Clinical Quality (IDE, GCLP, and CLIA)

• Full-time Company Description Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics. The Guardant Health Oncology Platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has launched liquid biopsy-based Guardant360--, Guardant360 CDx and GuardantOMNI-- tests for advanced stage cancer patients. These tests fuel development of its LUNAR program, which aims to address the needs of early stage cancer patients with neoadjuvant and adjuvant treatment selection, cancer survivors with surveillance, asymptomatic individuals eligible for cancer screening and individuals at a higher risk for developing cancer with early detection. Job Description As a member of the Regulatory and Quality Leadership team at Guardant Health, the Director Clinical Quality will play an integral role in the development and implementation of Quality focused Clinical support activities and philosophies across Guardant Health (e.g., Quality Systems, Clinical Operations Systems, Outcomes and Evidence, etc.). The Director Clinical Quality will work cross-functionally to be a driver for streamlined, risk-based, scalable, and sustainable systems and programs which will enable growth at Guardant Health. This role must be able to work across boundaries and a variety of organizational roles to accomplish these tasks. Note: For the purposes of this job description the scope of Clinical Quality is defined as Clinical Trial support, Outcomes and Evidence support, Device performance studies, etc. Essential Duties and Responsibilities:
  • Responsible for successful development, deployment and maintenance of the global Clinical Quality program, which would include but not be limited to, business processes, tools, templates and training
  • Responsible for Clinical Quality activities which result in the highest levels of data integrity and Quality outcomes.
  • Responsible for the development of strategic Quality activities (Monitoring, auditing, etc.) which assure Quality outcomes from these important clinical activities
  • Responsible to influence across boundaries to assure understanding and execution of Quality deliverables.
  • Responsible for creating, communicating and coordinating procedures and tactics which improve clinical Quality decision making and associated processes
  • Create and maintain quality metrics required for management review
  • Develop, mentor and train personnel and internal customers on quality in the clinical setting. Provide guidance, and support the company for other QMS related activities
  • Ensure processes are in place that lead to the delivery of quality results and continually assess their effectiveness to drive continual improvement
  • Execute special projects as assigned
  • Report and document all concerns of test quality and/or safety to the Supervisor or Safety Officer, as applicable.
  • Collaborative Leadership - Ability to influence with or without authority, facilitate groups with diverse perspectives, bring teams to alignment. Ability to foster effective inter-departmental and cross-functional partnerships. High tolerance for ambiguity, able to create order from chaos.
  • Ownership and Accountability - Takes accountability for actions, drives results, learns from mistakes. Is direct and truthful and therefore widely trusted - delivers on promises, goals, and expectations. Makes quality decisions and resolves problems rapidly. Asks "what can I do to help?".
  • Decision Making - Ability to make sound decisions on quality related subjects, scheduling, allocation of resources, and managing priorities
  • Communication - Ability to communicate effectively (verbal and written) up and down, across all levels of the organization throughout various departments; present complex and/or new ideas with clarity and simplicity.
  • Planning/Organization - Excellent planning and prioritization skills with the ability to multi-task and adapt. Successfully balances and prioritizes multiple ongoing projects/tasks in a fast-paced, deadline driven environment. Able to synthesize large amount of information. Able to deliver results despite shifting environment.
  • Analytical Problem Solving - Ability to identify problems, define problem statement clearly and accurately, and apply structured and disciplined methodology to identify data-driven root causes. Innovative and effective in solution development, risk mitigation, and execution.
  • Customer focused - Partners with customers, looks ahead to predict future customer needs. Manages expectations. Qualifications
    • B.S. degree in a Science or Engineering discipline. Advanced degree preferred
    • Experience in leading in the Clinical, Investigational, and outcomes based setting
    • 5-7 years experience in Life Science Industry (e.g. medical device, pharmaceutical or biopharmaceutical) in the Quality and Regulatory environment
    • Proven experience related to IDE, GCLP, and CLIA requirements.
    • Strong working knowledge of cGMPs, Quality System Regulations, ISO 13485, ISO 14971 regulations.
    • Experience in compliance with quality standards in a regulated Molecular Diagnostics laboratory, and Laboratory Workflows preferred
    • Experience with risk management and ability to utilize risk-based approaches to prioritize and take appropriate actions Additional Information Employee may be required to lift routine office supplies and use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and biohazard material in the laboratory environment. Ability to sit for extended periods of time. Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. All your information will be kept confidential according to EEO guidelines. To learn more about the information collected when you apply for a position at Guardant Health, Inc. and how it is used, please review our--Privacy Notice for Job Applicants . Director Clinical Quality (IDE, GCLP, and CLIA)

Keywords: Guardant Health, San Diego , Director Clinical Quality (IDE, GCLP, and CLIA), Executive , San Diego, California