Position Overview:

Role: Bioinformatics Product Owner

Location: Remote (PST Hours)

Contract

Duration: 6+ months with a high possibility of extension

Job Summary

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.

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.
• Collaborate with stakeholders (Clinical Development, Laboratory Operations, Medical Affairs, Bioinformatics, Engineering) to optimize NGS pipeline performance and data analysis.
• 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.
• Apply in-depth bioinformatics knowledge to refine NGS pipeline, variant analysis, and clinical reporting.
• 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 Skills & Qualifications

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.

Key Skills – Quick Reference

• In-depth knowledge in Bioinformatics.
• Cancer Genomics.
• Whole Genome, Whole Exome Sequencing and Transcriptomics analysis.
• Understanding of NGS Tools and applications.
• NGS Pipeline and data analysis.
• Downstream analysis of NGS data.
• Requirement gathering and refinement expertise.
• Knowledge of SDLC.
• Documentation.
• FDA Compliance knowledge.
• Knowledge of guidelines to follow on cancer genomics.
• Experience working as a Product Owner.
• Task prioritization.
• Delivery-oriented mindset.
• Excellent communication and teamwork skills.
• Great attention to detail.
• Organizational skills.
• Analytical mindset.
• JIRA & Confluence.

Other Job Details

• Work Schedule: PST Hours
• Interviews: Video interviews.
• Docs required: ID proof will be required.
• Availability: Candidates able to join immediately are preferred