Full Job 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.
As a member of the Regulatory and Quality Leadership team at Guardant Health, the Senior Director Regulatory Affairs will play an integral role in the development and implementation of risk-based programs and philosophies across Guardant Health (e.g., Regulatory Strategy, Communication Strategy, External Influencing, etc.). The Senior Director Regulatory Affairs will work cross-functionally to be a driver for streamlined Regulatory and External Influencing programs which will enable growth at Guardant Health. This role must be able to work across boundaries and influence a variety of organizational roles to accomplish these tasks.
Essential Duties and Responsibilities, would include but not be limited to:
Responsible for successful development of Global Regulatory Policies, Strategies and Tactics which result in worldwide registrations and approvals.
Responsible for providing leadership related to interactions with US-FDA and other regulatory bodies to expedite approval of applications and other regulatory matters.
Responsible for cross-functional collaboration with Government Affairs to assist and develop External Influencing strategies and tactics which support Guardant Health’s position in the market place.
Would support policy development related to regulatory and legislative topics relevant to Guardant Health.
Would participate in meetings with policymakers, as needed, specific to FDA oversight and IVD reform legislation
Would represent Guardant Health with relevant membership organizations (e.g., AdvaMed, Personalized Medicine Coalition, Medical Device Innovation Consortium) as needed
Interprets US-FDA and other global Medical Device regulation and provides guidance to project teams.
Provides strategic input and guidance on regulatory requirements to the Regulatory Affairs teams and R&D project teams.
Responsible for creating, communicating and coordinating procedures and tactics which improve Regulatory-based decision making and associated processes
Leadership in providing regulatory due diligence and advice for potential new product opportunities
Develop, mentor and train personnel and internal customers on Regulatory Affairs applications, tools and processes. 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
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 regulatory 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.
Required to have significant US-FDA reviewer experience in a relevant IVD review team
Understands US-FDA intent rather than just requirements
B.S. or advanced degree in Biological, Medical or other appropriate scientific discipline
A minimum of 10 years of experience in Life Science Industry and Regulatory Review (e.g. medical device, IVD, biopharmaceutical, etc.).
Strong working experience and knowledge of global medical device regulation and standards for IVD products
Has experiences and working relationships that provide better context and understanding related to interactions with US-FDA and other regulatory bodies
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.
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