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The Program Manager for IVD Development is a key leadership role on the team. Your primary responsibility will be to lead a complex, multi-disciplinary core team to launch IVD products that meet critical unmet needs for cancer patients.
You will lead a cross functional core team in the development of an in vitro diagnostic NGS assay, ensuring delivery of the product through launch while ensuring compliance with our quality system deliverables and regulatory requirements. Experience with IVD or Medical Device product development will be critical to the success of this role.This position will primarily focus on supporting Guardant Health’s projects in the AMEA (Asia, Middle East, and Africa) regions.
You will be responsible for setting up and kicking off projects, aligning with the internal and external teams, and overseeing the execution of clinical studies that support a future IVD submission.
Responsibilities:Bachelor’s degree in a business or a technical discipline PLUS4 to 7 years relevant experienceOR a Master's degree with 3-5 years relevant experience.
An advanced degree in either business or a technical field is desired. Specific IVD experience can supplement years of experience and education requirements
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.
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