Sr. Technical Product Manager -- Bioinformatics

Tempus AI · Vertical AI · IL · Remote

Sr. Technical Product Manager for Bioinformatics at Tempus AI, focusing on precision medicine and advancing healthcare. The role involves managing the software development lifecycle for bioinformatics software, ensuring quality and regulatory compliance, and supporting stakeholders in a regulated environment. Requires experience in medical device development, diagnostics, and regulatory frameworks like FDA and IVDR.

What you'd actually do

  1. Managing software development lifecycle processes.
  2. Engaging with the quality and regulatory team and supporting quality processes.
  3. Incident management: Promptly triage, coordinate, and manage the resolution of issues.
  4. Stakeholder support: Provide dedicated and responsive support to all stakeholders using the bioinformatics software.
  5. Feature request intake and prioritization: Collect, prioritize, and manage feature requests to guide software development.

Skills

Required

  • Bachelors or M.S. in a scientific discipline
  • Significant experience in medical device development and regulatory submission
  • 2-4 years relevant experience in diagnostics product development
  • Familiarity with US FDA and EU IVDR regulatory frameworks.

Nice to have

  • A track record of successful submissions to US and international regulatory agencies
  • Experience in cancer genetics, immunology, or molecular biology
  • Experience working with next-generation sequencing data
  • Self-driven and works well in interdisciplinary teams
  • Experience with communicating insights and presenting concepts to a diverse audience

What the JD emphasized

  • significant experience in regulated device development
  • extensive experience and interest in translational cancer research, diagnostic test development, and systems validation and verification
  • experience with diagnostic products, clinical regulatory requirements for software systems, and algorithms development
  • Significant experience in medical device development and regulatory submission
  • Familiarity with US FDA and EU IVDR regulatory frameworks.