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Company | Guardant Health |
Address | Palo Alto, CA, United States |
Employment type | FULL_TIME |
Salary | |
Category | Biotechnology |
Expires | 2023-07-03 |
Posted at | 11 months ago |
Company Description
- Ensure timely team completion of documents required for the product design history file
- Lead the team to prepare for phase gate reviews and other go/no go decisions required by executive leadership
- Define program resource needs, negotiate program resourcing plans, and track resource usage throughout the program
- Perform other related duties and assignments as required
- Manage leadership stakeholders and present at executive management forums
- Lead the team through problem resolution including root cause analysis and corrective action
- Lead a cross-functional product development core team in the execution of deliverables. Work closely with R&D, Operations, Quality, Marketing, Regulatory, Medical Affairs, and other departments to ensure project priorities and decisions are consistent between teams and corporate strategic plans
- Lead a cross-functional joint project team with external partners to align and execute the project per contractual milestones
- Lead the program planning, monitoring, and reporting
- Ensure effective communications with the Core Teams using a variety of tools and channels
- Communicate program updates to the core team, to functional management, and executive leadership both internally and externally
- Lead team efforts to mitigate risks and resolve issues quickly as they arise
- Experience working in FDA-regulated environments is required
- PMP or similar certification is highly desired
- Bachelors degree in a business or a technical discipline. An advanced degree in either a business or a technical field is desired. Relevant experience of 5 to 8 years with BS/BA and 3-5 years with a Masters degree in addition to meeting the experience requirements
- Expert-level knowledge of Program / Project Management tools such as project scheduling, work breakdown structures, and time and cost reporting is required.
- 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
- Experience in product development for NGS assays is required
- Experience with both Agile and Waterfall program management is preferred.
- Experience working in team environments is required.
- Experience leading core teams to successfully launch medical devices or in vitro diagnostic products is highly desired
- Specific experience managing complex system programs with multiple sub-projects as part of a complete solution is required
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