Vice President, Laboratory Software Engineering New US Remote

The Vice President of Laboratory Software Engineering is an enterprise executive role responsible for the strategy, modernization, and delivery of informatics platforms that power sample accessioning, order and sample tracking, and end-to-end workflow orchestration across both wet and dry laboratories.

This role leads an organization of approximately 200 people and supports multiple business units, including Oncology Minimal Residual Disease (MRD), Oncology Comprehensive Genomic Profiling (CGP), Early Cancer Detection (ECD), Women's Health (WH), and Organ Health (OH).

Operating in a CLIA- and CAP-certified clinical laboratory environment with FDA-regulated diagnostics, the VP will lead the transformation of a fully homegrown informatics ecosystem. The leader is accountable for defining enterprise platform strategy, driving large-scale modernization, and making critical build-vs-buy decisions to ensure scalability, reliability, regulatory compliance, and operational excellence. First 90 Days

The VP is expected to build strong relationships with laboratory, product, engineering, quality, and regulatory stakeholders; develop a deep understanding of existing informatics platforms and laboratory workflows; assess organizational strengths and gaps; and establish credibility with laboratory users through direct engagement, including onsite interaction.

They should also identify near-term risks and opportunities while defining clear principles for platform modernization. First Year

The VP is expected to define and begin executing a multi-year enterprise informatics roadmap, make key architectural and build-vs-buy decisions, align the organization around standardized platforms, and demonstrate measurable improvements in scalability, reliability, and operational efficiency. Success will be reflected in stronger partnership with laboratory operations, improved readiness for regulatory audits, and tangible progress toward a modern, enterprise-grade informatics ecosystem that supports current and future business growth. Key Responsibilities Enterprise Informatics Strategy & Platform Modernization

Define and own the enterprise laboratory informatics strategy spanning sample accessioning, order management, sample tracking, and workflow orchestration across wet labs, dry labs, and downstream data consumers.

Lead the modernization of a predominantly homegrown informatics landscape, including architectural redesign, platform consolidation, and technology standardization.

Drive strategic build-vs-buy decisions, including vendor evaluation, platform selection, and long-term ownership models.

Establish and execute a multi-year roadmap that supports enterprise growth, new product introductions, and evolving regulatory expectations. Clinical Operations Enablement & Scalability

Ensure informatics platforms reliably support high-throughput, mission-critical laboratory operations across Oncology, Women's Health, and Organ Health portfolios.

Partner closely with laboratory operations, product, R&D, quality, and regulatory teams to optimize workflows, increase automation, and reduce operational friction.

Enable rapid onboarding of new assays and laboratory workflows while maintaining system stability, data integrity, and compliance.

Define and track KPIs related to system performance, availability, throughput, and operational efficiency. Leadership & Organization Development

Lead, mentor, and scale a high-performing organization of approximately 200 professionals across laboratory applications engineering, workflow platforms, data systems, validation, and operations support.

Build strong leadership bench strength and succession plans across a geographically distributed organization.

Foster a culture of technical excellence, accountability, customer focus, and continuous improvement.

Evolve organizational structures and operating models toward enterprise platforms rather than siloed, business-unit-specific systems. Regulatory, Quality & Risk Management

Ensure informatics platforms meet regulatory and quality requirements, including CLIA, CAP, HIPAA, FDA-regulated diagnostics (including LDTs), and applicable GxP standards.

Own or closely partner on Computer System Validation (CSV), audit readiness, change management, and system lifecycle governance.

Establish policies and controls to ensure data integrity, traceability, security, and privacy across the laboratory informatics ecosystem.

Serve as a senior informatics leader during regulatory inspections and audits. Cross-Functional & Executive Partnership

Act as a key executive partner to laboratory leadership, product management, engineering, quality, regulatory, and commercial teams.

Translate complex scientific, operational, and regulatory needs into scalable informatics solutions.

Communicate platform strategy, risks, and tradeoffs clearly to executive leadership and other stakeholders.

Maintain strong relationships with laboratory users through regular engagement, including onsite interaction in San Carlos, CA and Austin, TX as needed.

• 15+ years of progressive experience in laboratory informatics, enterprise software platforms, or large-scale systems supporting regulated, mission-critical environments.
• Demonstrated success leading large, complex organizations (100+ people), preferably at the VP or equivalent senior leadership level.
• Deep understanding of laboratory workflows, including sample accessioning, order and sample tracking, and wet-lab and dry-lab orchestration.
• Proven experience modernizing Legacy or homegrown platforms, including leading major architectural transformations and build-vs-buy decisions.
• Strong executive presence with the ability to influence across functions and communicate effectively with technical and non-technical stakeholders.

Preferred

• Experience supporting CLIA- and CAP-certified clinical laboratories.
• Familiarity with FDA-regulated diagnostics, LDTs, and regulatory submissions.
• Hands-on experience with CSV, audit readiness, and regulated system lifecycle management.
• Background in genomics, oncology diagnostics, or other high-throughput laboratory environments.

Competitive compensation package, including base salary, performance-based incentives, equity participation, and comprehensive benefits. Specific details will be based on experience and location. Equal Opportunity Statement