Senior Product Manager - IVD's at Tempus
Passionate about precision medicine and advancing the healthcare industry?
Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.
As a Senior Product Manager - IVDs at Tempus, you will be responsible for bringing new in vitro medical device assays through the R&D and regulatory review processes and supporting their launch and operationalization. The software and assays we’re developing is the culmination of input from scientists, clinicians, pathologists, engineers, data scientists, and some of the top academic oncology centers in the world. We’re expanding the team of product managers who bring those inputs together to design, scope, and build solutions to some of the toughest problems in cancer care.
What You'll Do:
- Partner with teams of scientists, engineers, operations, and designers to develop creative and elegant solutions to help advance patient care
- Own the roadmap for integrating new clinical assays into existing systems to support launch and operationalization
- Ensure that new products are built and supported in a manner compliant with Tempus’ Quality Management System, regulatory requirements, and industry best practices
- Derive insights from data to guide the short- and long-term roadmap for the team
- Own stakeholder communication and expectation management around roadmap and delivery timelines
- Lead operational change management for production updates and any related workflow impacts
- Model a can-do and mission-driven attitude and willingness to take on new tasks, projects, and responsibilities
- Identify the root causes of problems and make system-level changes to address them
- 5-10 years of experience working with innovative FDA cleared/approved medical devices that include complex software functions (experience with FDA approval process preferred)
- Practical knowledge of and experience with FDA’s QSR and ISO13485 standards
- Experience working with agile software development teams
- A history of building and using product analytics to drive decisions using tools such as SQL, Tableau, Plotly
- Experience with software development and project management tools (JIRA, Trello, etc.)
- Ability and interest to quickly ramp up on new concepts in the fields of genomics, oncology
- Responsive to feedback, willing to change direction, and able to identify creative solutions to meet business and regulatory needs
- Highly organized and systematic, superb attention to detail and ability to get things done quickly and accurately
- Excellent written and verbal communication skills, including the ability to act as a translator among diverse teams of biologists, medical professionals, engineers, operators, and data scientists.