Description
We are seeking a Director, Technical Product Management to help grow the Freenome Product Management team. The ideal candidate is a seasoned leader who bridges the gap between complex molecular biology and scalable software products in a regulated environment.
This person is responsible for the technical roadmaps, feature prioritization, software requirements, and specification definition related to Lab Information Management Systems (LIMS), laboratory automation, and software managing sample processing-to-result generation.
You will define and execute the multi-year technical roadmap for IVD/LDT software platforms, ensuring alignment with clinical needs and regulatory requirements.
Key responsibilities include:
- Leading feature prioritization and software requirements definition of LIMS, lab automation, and software managing the sample processing-to-result generation to optimize high-throughput sample processing and data integrity.
- Directing the integration of complex diagnostic hardware with cloud-based or on-premise processing software, focusing on seamless end-to-end workflows.
- Ensuring all software products comply with global regulatory standards, including FDA, CLIA/CAP, ISO 13485, and HIPAA/GDPR data privacy requirements.
- Collaborating with R&D, Molecular Biology, Clinical Lab, Lab Automation, and Engineering teams to translate complex assay protocols into automated, scalable software requirements.
- Managing cross-functional dependencies between wet-lab operations, bioinformatics pipelines, and software engineering teams to ensure timely product delivery.
- Establishing and monitoring key performance indicators (KPIs) for software reliability, processing speed, and diagnostic accuracy in a clinical laboratory environment.
Requirements include:
- 8+ years in Technical Product Management, with at least 4 years specifically in IVD, Medical Devices, or Clinical SaaS.
- Proven experience with LIMS/LIS and laboratory automation workflows.
- Deep familiarity with FDA software guidelines and CLIA regulations.
- BS/MS in Computer Science, Bioengineering, Molecular Biology, or a related field.
- Demonstrated experience managing and scaling technical product teams in a regulated environment.
Nice to have qualifications include:
- MS or PhD in a technical or scientific field.
- Experience with Next-Generation Sequencing (NGS) data pipelines.
- Hands-on experience with cloud infrastructure (AWS/Azure/GCP) in a GxP environment.
The US target range of our base salary for new hires is $220,400 - $281,400. You will also be eligible to receive equity, cash bonuses, and a full range of medical, financial, and other benefits depending on the position offered.