出海雷达

生物信息学产品负责人 – 远程 (PST 时间)

Bioinformatics Product Owner – Remote (PST Hours)

其他限定地区（需当地身份）
公司OMG Technology
薪资未公开
工作地点United States
地域资格限定地区（需当地身份）
时区要求日间重叠约 9 小时，基本正常作息
用工类型Contractor
发布时间14 天前
数据来源Himalayas
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注意地域限制：该职位明确限定在 United States 招聘。如果你是位于中国大陆的求职者，通常需要当地工作身份才能投递，或需与雇主确认是否接受独立合同（Contractor）形式合作。

职位概述：
职位-生物信息学产品经理
地点-远程（PST 时间）
合同类型
时长：6 个月以上，有很高可能性延长
职位简介
我们正在寻找一位经验丰富的产品经理，推动一种尖端检测技术的开发，该技术旨在识别实体瘤患者的临床可操作突变。
此职位在确保软件开发、生物信息学、临床基因组学和监管团队之间的无缝协作方面至关重要，以交付高质量、合规且创新的精准肿瘤学软件解决方案。
主要职责

  • 定义并执行下一代测序（NGS）生物信息学流程及支持软件的产品路线图。
  • 优先处理并管理产品待办事项，确保与业务目标和临床需求一致。
  • 与利益相关者（临床开发、实验室运营、医学事务、生物信息学、工程）合作，优化 NGS 流程性能和数据分析。
  • 在 JIRA 和 Confluence 中定义史诗、用户故事和功能软件需求。
  • 与生物信息学家和工程师紧密合作，确保 NGS 数据分析和下游解读的无缝衔接。
  • 领导敏捷仪式（冲刺计划、待办事项梳理、冲刺评审和回顾）。
  • 在软件开发生命周期（SDLC）中为软件开发人员和 QA 团队提供业务和领域专业知识。
  • 编写计算机系统验证（CSV）文档，并确保符合 FDA 监管指南。
  • 运用深入的生物信息学知识，优化 NGS 流程、变异分析和临床报告。
  • 确保流程符合癌症基因组学指南（例如 CAP、AMP、FDA 和 CLIA 标准）。
  • 与数据科学家和生物信息学家合作，提升全基因组、全外显子组和转录组分析。
  • 与科学、技术和业务团队有效沟通，确保产品开发符合临床和监管要求。
  • 与监管团队合作，确保符合肿瘤诊断指南和 FDA 标准。
  • 与质量保证团队协作，制定支持 NGS 工作流的软件验证和确认测试计划。
  • 所需技能与资格
  • 领域专业知识
  • 生物信息学、癌症基因组学和 NGS 数据分析方面的扎实背景。
  • 具有 NGS 流程、全基因组、全外显子组和转录组工作流的经验。
  • 熟悉临床基因组学指南（FDA、CLIA、CAP、AMP）
查看英文原文

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

Originally posted on Himalayas

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