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  Company Description

ABOUTOUR COMPANY

We believe conquering cancer is a big data problem. That's why we built the world's leading comprehensive liquid biopsy. This non-invasive tool for accessing & sequencing tumor DNA is used by thousands of oncologists to help tens of thousands of advanced cancer patients. We believe the boom in cancer data acquisition we helped launch will drive important discoveries & new products. We're working on some exciting ones, including in early detection, where the impact on patients can be profound. We've raised more than $500 million from investors including Sequoia Capital, Khosla Ventures, OrbiMed, & SoftBank.

Job Description

About the Role:

The Senior 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 work closely with key stakeholders across the organization, including marketing, regulatory, medical affairs, reagent development & bioinformatics teams, among others. In addition, you will lead the joint project team with our external partners.

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 & other departments to ensure project priorities & decisions are consistent between teams & corporate strategic plans
  • Lead a cross functional joint project team with external partners to align & execute the project per contractual milestones
  • Communicate program updates to the core team, to functional management & to executive leadership both internally & externally
  • 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
Qualifications

Qualifications:

  • 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 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

Education:

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

Additional Information

All your information will be kept confidential according to EEO guidelines.

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