CDx Program Manager
- Kaigan, Minato-city, Japan
Guardant Health AMEA is a leading precision oncology company focused on helping conquer cancer through use of its proprietary blood tests, vast data sets and advanced analytics. Its Guardant Health Oncology Platform is designed to leverage its capabilities in technology, clinical development, regulatory and reimbursement to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs.
The Program Manager for CDx Development is a key leadership role on the team. Your primary responsibility will be to lead a complex, multi-disciplinary core team to launch CDx products that meet critical unmet needs for cancer patients.
You will lead a cross functional core team in the development and commercialization of Companion Diagnostics products for Guardant’s flagship product, Guardant360. You will ensure 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.
You will be responsible for setting up and kicking off projects, aligning with the internal teams, managing project communications with the biopharma development partner, and overseeing the execution of the project all the way to regulatory approval and reimbursement.
Essential Duties and Responsibilities:
- Lead a cross functional product development core team in the execution of deliverables. Work closely with R&D, Operations, Quality, Marketing, Regulatory, Medical Affairs, Business Development and other departments in Japan and the US to ensure project priorities and decisions are consistent between teams and corporate strategic plans
- Communicate program updates to the core team, to functional management and to executive leadership
- Ensure timely team completion of documents required for the product design history file
- Lead team efforts to mitigate risks and resolve issues quickly as they arise
- Lead the team through problem resolution including root cause analysis and corrective action
- Lead the team to prepare for phase gate reviews and other go/no go decisions required by executive leadership
- Lead the program planning process
- Ensure effective communications with the Core Teams using a variety of tools and channels
- Define program resource needs, negotiate program resourcing plans and track resource usage over the course of the program
- Build project budgets and manage project finances throughout the lifecycle of project
- Perform other related duties and assignments as required
- Experience working in team environments is required. Knowledge of Program / Project Management tools such as project scheduling, work breakdown structures, time and cost reporting is required
- Experience working in PMDA submissions or clinical studies is required
- Experience leading core teams to successfully launch medical devices or in vitro diagnostic products is highly desired
- Position requires the ability to collect information from multiple sources, sort through, integrate, and resolve often conflicting requirements, and drive an organization through the various issues to result in a successful product launch
- Working in an international environment and with English-speaking teams is required
- Experience with both Agile and Waterfall program management, PMP certification preferred
- Bachelor’s degree in a business or a technical discipline. An advanced degree in either business or a technical field is desired.
- PMP or similar certification is highly desired
Guardant Health AMEA 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.
Please visit our career page at: https://www.guardanthealthamea.com/
If you think you are:
- Drive for results
- Dealing with Ambiguity
- Customer focus
- Peer Relationships
- Intellectual horsepower
Please apply to this position!