Company Description|Job Description
Guardant Health develops breakthrough diagnostic technologies to improve cancer management. With Guardant360, we offer real-time, biopsy-free tumor sequencing that tracks tumor genomics in real-time & identifies associated treatment options. The assay is used by more than 6,000 oncologists & we partner with more than 50 biopharma companies.
Guardant Health raised over $550M from Sequoia Capital, Khosla Ventures, Lightspeed Ventures, OrbiMed & Softbank, before having a successful IPO on NASDAQ in 2018. Guardant is led by a seasoned management team of thought leaders & successful serial entrepreneurs in next generation sequencing & rare cell diagnostics. They are advised by an oncologist-led medical steering committee from leading cancer centers.
About the Role:
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 & 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 & kicking off projects, aligning with the internal teams, & overseeing the execution of clinical studies that support a future IVD submission.
- Lead a cross functional product development core team in the execution of deliverables. Work closely with R&D, Operations, Quality, Marketing, Regulatory, Medical Affairs & other departments to ensure project priorities & decisions are consistent between teams & corporate strategic plans
- Communicate program updates to the core team, to functional management & to executive leadership
- Ensure timely team completion of documents required for the product design history file
- Lead team efforts to mitigate risks & resolve issues quickly as they arise
- Lead the team through problem resolution including root cause analysis & corrective action
- Lead the team to prepare for phase gate reviews & 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 & channels
- Define program resource needs, negotiate program resourcing plans & track resource usage over the course of the program
- Perform other related duties & assignments as required
- Experience working in team environments is required. Knowledge of Program / Project Management tools such as project scheduling, work breakdown structures, time & cost reporting is required.
- Experience working in FDA-regulated environments 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, & resolve often conflicting requirements, & drive an organization through the various issues to result in a successful product launch
- Experience with both Agile & Waterfall program management, PMP certification preferred
Bachelors degree in a business or a technical discipline.An advanced degree in either business or a technical field is desired. Relevant experience of 4 to 7 years with BS/BA & 3-5 years with Masters degree
PMP or similar certification is highly desired
All your information will be kept confidential according to EEO guidelines.