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