VP of Science

The OpportunitySiPhox Health is seeking a Vice President of Science to lead the scientific organization responsible for assay development, assay chemistry, reagent manufacturing science, verification and validation, and quality control. This executive will establish the scientific strategy and operating system that turns biomarker concepts into robust, manufacturable, clinically credible, and regulatory-ready diagnostic products.The VP of Science will lead three director-level functions and integrate their work into one accountable development and product-lifecycle organization. The role requires broad scientific judgment, a strong command of quantitative immunoassays and diagnostic development, and the ability to make disciplined decisions across performance, risk, schedule, manufacturability, and regulatory evidence.Role Mandate- Own the scientific strategy, organization, and execution model for SiPhox assay products from feasibility through commercial lifecycle management.- Create clear accountability and effective interfaces among Assay Development, Assay V&V and Quality Control, and Assay Chemistry and Reagent Manufacturing.- Ensure scientific work produces decision-quality evidence, transferable processes, defensible specifications, and products that meet user, business, manufacturing, and regulatory needs.- Build a high-performing scientific organization with the leadership depth, technical systems, and execution discipline required to scale.Key ResponsibilitiesScientific and Product Strategy- Define the scientific roadmap for the assay platform, biomarker portfolio, chemistry platform, critical reagents, analytical validation, and lifecycle improvement.- Translate company and product priorities into scientific programs with clear hypotheses, technical requirements, milestones, resources, decision gates, and risk-reduction plans.- Set platform standards for analytical performance, precision, sensitivity, specificity, dynamic range, interference, robustness, stability, manufacturability, and clinical relevance.- Evaluate new biomarkers, assay formats, detection approaches, reagents, methods, partnerships, and platform capabilities using rigorous technical and business criteria.- Advise executive leadership on scientific feasibility, program risk, portfolio tradeoffs, investment priorities, and product claims.Integrated Functional Leadership- Lead the Director of Assay Development, who owns assay architecture, biomarker-specific development, optimization, feasibility, and transfer readiness.- Lead the Director of Assay V&V and Quality Control, who owns formal verification and validation execution, analytical study readiness, QC methods, lot-release support, stability programs, and performance trending.- Lead the Director of Assay Chemistry and Reagent Manufacturing, who owns surface chemistry, conjugation, formulations, critical reagents, process development, scale-up, and controlled reagent manufacturing.- Define handoffs, shared deliverables, technical authorities, and escalation paths so programs move efficiently from development into V&V and routine manufacturing.- Resolve cross-functional scientific issues that span assay design, reagents, sensor surfaces, cartridge behavior, instrument performance, manufacturing variation, and data analysis.Development and Technical Governance- Establish development standards for experimental design, data integrity, statistical analysis, documentation, design reviews, acceptance criteria, and technical decision-making.- Chair or sponsor scientific and assay design reviews, ensuring that risks, assumptions, failure modes, and unresolved questions are visible and acted upon.- Ensure design inputs, outputs, traceability, risk controls, assay specifications, and evidence packages are scientifically coherent and aligned.- Drive root-cause investigations for complex or systemic assay failures and ensure corrective actions address underlying mechanisms rather than symptoms.- Build platform knowledge and reusable methods that shorten development cycles and reduce dependence on biomarker-by-biomarker reinvention.Regulatory and Clinical Readiness- Partner with Regulatory, Quality, Clinical, and Systems Engineering to define evidence strategies for FDA submissions and product claims.- Ensure analytical study plans are fit for purpose and appropriately address precision, linearity, detection capability, interference, cross-reactivity, method comparison, matrix effects, stability, and robustness.- Provide scientific leadership for regulatory interactions, technical files, responses to agency questions, audits, and inspections.- Ensure clinical and usability programs receive scientifically representative product, well-defined acceptance criteria, suitable controls, and reliable data interpretation.- Maintain clear separation of responsibilities while ensuring development, V&V, QC, and manufacturing data form one coherent evidence package.Manufacturing Science and Product Lifecycle- Ensure assays and reagent processes are designed for scale, reproducibility, supply continuity, cost, shelf life, and operational control.- Oversee scientific strategy for critical-reagent qualification, comparability, lot bridging, reference materials, calibrators, controls, and supplier or process changes.- Partner with Operations, Supply Chain, and Quality on process capability, lot acceptance, deviations, CAPA, yield improvement, and production readiness.- Establish lifecycle monitoring that detects drift, emerging risks, and improvement opportunities across lots, instruments, sites, and field performance.- Provide scientific oversight for post-launch changes and determine when additional verification, validation, clinical evidence, or regulatory assessment is needed.Organization and Executive Leadership- Build and develop an organization of scientific leaders, assay scientists, chemists, process engineers, V&V specialists, QC personnel, and reagent-manufacturing staff.- Set objectives, operating rhythms, staffing plans, budgets, and performance expectations across the scientific organization.- Develop succession depth and coaching systems for director-level leaders and emerging technical leaders.- Communicate scientific status, risks, decisions, and resource needs clearly to executive leadership and the board when appropriate.- Represent SiPhox externally with scientific collaborators, key suppliers, clinical partners, regulators, advisors, and strategic partners.Decision Rights and InterfacesAreaVP of Science accountabilityKey partnersScientific strategyOwns platform and assay scientific direction, priorities, standards, and technical decisions.CTO, CEO, ProductAssay programsAccountable for integrated delivery from feasibility through transfer, V&V, and lifecycle support.Three director functions, Program ManagementRegulatory evidenceAccountable for scientific completeness and defensibility of analytical evidence.Regulatory, Quality, ClinicalReagent manufacturing scienceAccountable for technical readiness, capability, comparability, and lifecycle strategy.Operations, Supply Chain, QualitySystem performanceOwns assay-side decisions and jointly resolves cross-system tradeoffs.Hardware, Software, Systems EngineeringQualificationsRequired- PhD in biochemistry, chemistry, bioengineering, chemical engineering, biomedical engineering, immunology, molecular biology, or a related scientific discipline.- Typically 12 or more years of relevant industry experience, including substantial leadership of multidisciplinary scientific or diagnostic-development teams.- Deep experience developing quantitative immunoassays, biosensors, in vitro diagnostics, or closely related regulated diagnostic products.Product leadership. Demonstrated success leading products from feasibility through design control, transfer, analytical validation, regulatory submission, and commercial support.- Broad technical fluency across assay development, surface or reagent chemistry, critical reagents, analytical performance, process development, V&V, QC, and statistics.- Strong understanding of experimental design, method validation, risk management, specifications, traceability, and data-driven technical decision-making.- Experience building organizations, managing senior leaders, allocating resources, and delivering complex cross-functional programs under schedule constraints.- Executive-level communication skills and the judgment to communicate uncertainty, risk, and tradeoffs clearly.PreferredEspecially relevant backgrounds include point-of-care or home-use diagnostics, capillary blood, microfluidics, silicon photonics, optical biosensors, and multiplexed assay platforms.- Experience with FDA 510(k) submissions, ISO 13485, design controls, the FDA Quality Management System Regulation, and regulated manufacturing scale-up.- Experience establishing V&V and QC organizations, critical-reagent programs, or reagent-manufacturing capabilities.- Track record of supporting clinical studies, regulatory interactions, inspections, commercial launch, and post-market product changes.- Experience working in a fast-growing company where leaders combine strategy with direct engagement in technical details.Measures of Success- A coherent scientific roadmap and operating model that align assay development, chemistry, V&V, QC, and reagent manufacturing around product milestones.- Timely delivery of robust assays, representative lots, validation evidence, and regulatory-ready documentation.- Measurable improvement in development cycle time, assay performance, lot consistency, stability, process capability, yield, and scientific decision quality.- Clear technical ownership, effective director-level leadership, and rapid resolution of cross-functional risks.- A scalable scientific organization with strong talent, documented platform knowledge, and reduced key-person dependency.- Credible scientific leadership with regulators, partners, customers, advisors, and the company leadership team.Working StyleThe VP of Science should be an enterprise-minded scientific leader who can operate at multiple levels: setting strategy, coaching directors, reviewing data, resolving technical disagreements, and making practical decisions under uncertainty. The right leader will value rigor without bureaucracy, insist on clear evidence and ownership, and remain close enough to the science to recognize important risks early.