Senior Bioinformatics PM – Regulated Diagnostics

Tempus; Chicago (IL); On-site; USD 105,000 - 145,000; Full time

Job summary

Tempus seeks a Sr. Technical Product Manager for Bioinformatics Software to lead the development of regulated analytic software for precision oncology.

You will coordinate with bioinformatics, regulatory, and quality teams to ensure lifecycle management, documentation, and successful regulatory submissions. Experience with diagnostic products and sequencing data is highly valued, as is collaboration across interdisciplinary teams.

Qualifications

• Bachelor's or MS 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.

Responsibilities

• Managing software development lifecycle processes.
• Engaging with the quality and regulatory team and supporting quality processes.
• Incident management: triage, coordinate, and resolve issues.
• Stakeholder support for the bioinformatics software.
• Feature request intake, prioritization, and guidance for software development.
• Interfacing with Product Managers of downstream engineering teams during implementation.
• Data contract management with downstream engineering teams.
• Documentation: maintain up-to-date documentation for all bioinformatics software.

Skills

Medical device development

Regulatory submissions

Diagnostics product development

FDA regulatory

Education

Bachelors or MS in a scientific discipline

Job description

Tempus seeks a Sr. Technical Product Manager for Bioinformatics Software to lead the development of regulated analytic software for precision oncology.

You will coordinate with bioinformatics, regulatory, and quality teams to ensure lifecycle management, documentation, and successful regulatory submissions. Experience with diagnostic products and sequencing data is highly valued, as is collaboration across interdisciplinary teams.