Job Description
About this opportunity:
At Freenome, 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 are passionate about building seamless, high-throughput clinical workflows that ensure data integrity and regulatory compliance, and you will have a significant impact on the continued growth of an organization dedicated to changing the entire landscape of cancer.
The role reports to the Director, Product Management. This role will be a Hybrid role based in our Brisbane, California headquarters.
What you’ll do:
- Define and execute the multi-year technical roadmap for IVD/LDT software platforms, ensuring alignment with clinical needs and regulatory requirements.
- Lead 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.
- Direct the integration of complex diagnostic hardware with cloud-based or on-premise processing software, focusing on seamless end-to-end workflows.
- Ensure all software products comply with global regulatory standards, including FDA, CLIA/CAP, ISO 13485, and HIPAA/GDPR data privacy requirements.
- Collaborate with R&D, Molecular Biology, Clinical Lab, Lab Automation, and Engineering teams to translate complex assay protocols into automated, scalable software requirements.
- Ensure compliance to Software Development Life Cycle (SDLC) for diagnostic products, from initial concept to commercial launch for deliverables owned by Technical Product Management.
- Manage cross-functional dependencies between wet-lab operations, bioinformatics pipelines, and software engineering teams to ensure timely product delivery.
- Establish and monitor key performance indicators (KPIs) for software reliability, processing speed, and diagnostic accuracy in a clinical laboratory environment.
Must haves:
- 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 haves:
- 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.
Benefits and additional information:
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. Please note that individual total compensation for this position will be determined at the Company’s sole discretion and may vary based on several factors, including but not limited to, location, skill level, years and depth of relevant experience, and education. We invite you to check out our career page @ _freenome.com/job-openings/_ for additional company information.
Freenome is proud to be an equal-opportunity employer, and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.
Applicants have rights under Federal Employment Laws.
- Family & Medical Leave Act (FMLA)
- Equal Employment Opportunity (EEO)
- Employee Polygraph Protection Act (EPPA)
#LI-HYBRID
