Clinical System Product Manager (LIS or LIMS)
PharmaBiotechRegulatory AffairsQuality Assuranceedcemacroinform
Job description
Company Description Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant® is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn , X (Twitter) and Facebook . We are seeking a Clinical Systems Product Manager, Operations, to serve as the critical bridge between operational requirements and software development for our internal LIS system. This role sits within the Operations team and is responsible for identifying, cataloging, synthesizing, and translating complex laboratory operational needs into clear, prioritized user requirements and actional development roadmaps. This individual will work at the intersection of clinical laboratory workflows, software architecture, and cross-functional collaboration. You will serve as an expert translator who helps laboratory operations articulate their needs in ways the software engineering team can execute while also ensuring the technical vision and long-term platform strategy remain coherent and scalable. Key Responsibilities Strategic Platform Vision and Architecture In partnership with Product, Software Engineering, and sample end-to-end operations teams, develop and communicate the long-term vision for LIS aligned with business strategy, clinical growth, regulatory commitments, and operational priorities. Understand software platform architecture, design principles, reusability patterns, and scalability implications. Identify opportunities to build shared services, workflows and data models that reduce redundancy and improve operational consistency. Balance short-term operational needs with long-term platform modernization and NPI activities. Requirements Collection and Discovery Systematically gather software requirements and enhancement requests from production critical teams. Map current-state and future-state workflows across pre-analytical, analytical, and post-analytical operations (End-to-end operations from sample order through sample report). Translate stakeholder feedback and operational observations and data into documented prioritized requirements. Consolidate competing or overlapping requests and identify common patterns and themes enabling similar requirements to be grouped into cohesive features. Requirements Translation and Road-Mapping Translate prioritized operational requirements into clear, technical user stories, swim lane diagrams, and wire frames as needed, enabling effective software design and development. Partner with software engineering to assess technical feasibility, identify architectural considerations, dependencies, and level of effort for proposed features. In partnership with Product and Software Engineering, develop and maintain a quarterly operations product roadmap aligned with operational priorities, regulatory requirements, and enterprise software architecture. Uses operational data and analytics to drive business insights, quantify improvement opportunities, and prioritize LIMS and workflow automation investments. Ensure creation of a multi-year vision for LIS capabilities, platform standardization and technical debt reduction. Product Lifecycle Management Oversee products and features from conception through design, development, testing, deployment and optimization Participate in sprint demos, support UAT and gather feedback to validate that delivered features meet operational needs Identify continuous improvement opportunities and feed learnings back into the roadmap Cross-Functional Collaboration and Prioritization Partner closely across end-to-end operations functions, Product, Software Engineering, Quality and Informatics to ensure alignment on priorities and feasibility. Act as a bridge between end-to-end operations functions and technical teams, translating domain language and technical concepts bidirectionally. Manage stakeholder expectations around timelines, scope, and trade-offs with high emotional intelligence and clarity. Facilitate collaborative decision-making when requirements conflict or resources are constrained. Required Skills and Competencies Bachelor’s degree in technical discipline (computer science, engineering, informatics, life sciences or related field) or equivalent professional experience. Eight or more years of experience in laboratory systems, process engineering, requirements management, product management, or technical program management. Demonstrated experience with a LIS or LIMS in a regulated clinical diagnostic lab. Strong knowledge of laboratory workflows, sample life cycle, accessioning, testing, result review and reporting, quality controls, and system integrations. Demonstrated experience gathering, synthesizing, and translating complex stakeholder requirements into clear technical specifications Working knowledge of product development processes, and software development lifecycles, regulated computer-system validation, change control, data integrity, and applicable requirements such as CLIA, CAP, and/or ISO standards. Proven track record working successfully across technical and non-technical teams in regulated environments. Experience with software architecture, platform design principles, and technical debt management. Measures of Success Requirement clarity: operational stakeholders report that their needs are well-understood, fairly prioritized, and clearly communicated to engineering. Delivery alignment: software engineering teams receive clear specifications and deliver features that meet operational expectations Roadmap execution: quarterly roadmaps are executed on schedule, and prioritized decisions reflect operational impact and technical health Stakeholder satisfaction: cross functional teams report high confidence in the LIS direction a
Stand out for this role
NoxPharm tailors your CV to this job description by aligning your experience with the role requirements and terminology. Built for pharma & life sciences.
Tailor my CV now — free to trySimilar Pharma jobs
Associate, Project Management (Pharmaceutical Labeling)
Open Scientific — Hauppauge, us
Maintenance Coordinator
Open Scientific — Bohemia, us
Manufacturing Operators - Pharmaceutical
Open Scientific — Melville, us
Pharmaceutical Mechanics - Packaging, Production, Maintanence
Open Scientific — Hauppauge, us
Warehouse - Pharmaceutical
Open Scientific — Hauppauge, us
Pharmaceutical Machine Operators
Open Scientific — Hauppauge, us