Bioinformatics Product Owner

Hello,

We are seeking an experienced Product Owner to drive the development of  a cutting-edge  test designed to identify clinically actionable mutations in patients with solid tumors. This role is crucial in ensuring seamless coordination across software development, bioinformatics, clinical genomics, and regulatory teams to deliver high-quality, compliant, and innovative software solutions for precision oncology.

Pay rate : $42 on W2 OR $48 on C2C

Location : Remote

Key Responsibilities:

• Define and execute the product roadmap for NGS bioinformatics pipeline and supporting software.

• Prioritize and manage the product backlog, ensuring alignment with business objectives and clinical needs.

• Define epics, user stories, and functional software requirements in JIRA & Confluence.

• Work closely with bioinformaticians and engineers to ensure seamless NGS data analysis and downstream interpretation.

• Lead Agile ceremonies (sprint planning, backlog grooming, sprint reviews, and retrospectives).

• Provide business and domain expertise to software developers and QA teams during SDLC.

• Develop documentation for computer systems validation (CSV) and ensure adherence to FDA regulatory guidelines.

• Ensure that the pipeline meets cancer genomics guidelines (e.g., CAP, AMP, FDA, and CLIA standards).

• Collaborate with data scientists and bioinformaticians to enhance whole genome, whole exome, and transcriptomics analysis.

• Communicate effectively with scientific, technical, and business teams to align product development with clinical and regulatory requirements.

• Work with regulatory teams to ensure compliance with oncology diagnostics guidelines and FDA standards.

• Coordinate with Quality Assurance to develop verification and validation test plans for software supporting NGS workflows.

Required Qualifications & Skills:

Domain Expertise:

• Strong background in Bioinformatics, Cancer Genomics, and NGS Data Analysis

• Experience with NGS pipelines, whole genome, whole exome, and transcriptomics workflows

• Knowledge of clinical genomics guidelines (FDA, CLIA, CAP, AMP)

Technical & Software Development Knowledge:

• Understanding of NGS tools, workflows, and cloud-based orchestration (AWS HealthOmics, Nextflow, etc.)

• Familiarity with software development lifecycle (SDLC), Agile methodologies, and documentation best practices

• Experience using JIRA & Confluence for requirement tracking and task management

Product Management & Leadership:

• Proven experience as a Product Owner in a bioinformatics, clinical genomics, or oncology-related software environment

• Strong requirement gathering, task prioritization, and delivery-focused mindset

• Excellent communication, teamwork, and stakeholder engagement skills

Regulatory & Compliance Knowledge:

• Familiarity with FDA regulatory requirements for genomics software

• Experience with computer system validation (CSV) and compliance documentation