Product Manager - Global NGS Diagnostic Applications

Accountabilities: Conduct market research, competitive analysis, and customer discovery across oncology diagnostics and NGS to identify market opportunities, competitive dynamics, and product differentiation. Define and maintain product requirements, target product profiles, application roadmaps, intended uses, product claims, naming, and value propositions based on customer needs, clinical utility, and business priorities. Prioritize product features and requirements while managing trade-offs across technical, clinical, regulatory, operational, and commercial considerations. Partner with regulatory teams and external regulatory specialists on companion diagnostic classification, submission planning, regulatory consultations, and vendor or contract reviews across global markets. Collaborate with pharmaceutical partners and alliance management teams to align diagnostic product strategies, clinical evidence plans, regulatory pathways, launch timelines, and commercialization objectives. Lead global and market-specific commercialization strategies, including launch plans, readiness milestones, lifecycle management, and alignment with regional regulatory, reimbursement, pricing, and pharmaceutical partner requirements. Support pricing, reimbursement, financial modeling, demand forecasting, transfer-pricing analysis, and market-sizing activities to inform commercialization decisions. Represent Product Management across cross-functional project teams, governance forums, and external partner committees, driving alignment, timely decisions, and resolution of commercialization risks. Monitor commercialization performance through KPIs such as launch readiness, site activation, customer adoption, market penetration, supply performance, and product lifecycle metrics, recommending corrective or growth actions. Lead customer-facing product engagements alongside scientific teams, including scientific presentations, advisory boards, conferences, payer discussions, and advocacy activities. Identify, assess, and oversee strategic testing partners such as contract laboratories, Centers of Excellence, reference laboratories, CROs, and other subcontracted organizations, including confidentiality, quality, and performance requirements. Partner with Marketing, Sales, and Scientific Affairs to develop positioning, messaging, launch materials, sales enablement resources, training, and educational content for laboratories, clinicians, and commercial teams. Requirements Bachelor’s degree in molecular biology, genetics, biomedical engineering, bioinformatics, life sciences, or a related discipline required; an MS, MBA, PhD, or equivalent advanced degree is preferred. At least 5 years of product management or commercialization experience within molecular diagnostics, genomics, biotechnology, or pharmaceuticals, with experience supporting NGS or molecular diagnostic applications. At least 3 years of direct experience with companion diagnostics, precision medicine applications, and pharmaceutical partnership programs. At least 3 years of experience supporting global product launches or regulatory submissions across multiple jurisdictions, including FDA and at least one international authority such as PMDA or EMA. Demonstrated experience developing commercialization strategies, launch-readiness plans, and market-specific execution plans within regulated diagnostic environments. At least 3 years of experience working with laboratory networks, CROs, Centers of Excellence, or decentralized testing models, including subcontractor governance and oversight. Strong technical understanding of NGS workflows, including library preparation, targeted sequencing, liquid biopsy, variant detection, and bioinformatics analysis. Familiarity with major sequencing platforms such as Illumina, Thermo Fisher, and Element Biosciences, with hands-on experience using Illumina platforms such as NextSeqDx or MiSeqDx. Working knowledge of market access, reimbursement, pricing, transfer-pricing negotiations, demand forecasting, TAM modeling, and reimbursement code or rate analysis. Exceptional communication, presentation, organizational, and stakeholder-management skills, with the ability to influence technical, clinical, commercial, regulatory, and external audiences. Strategic, analytical, customer-focused mindset with strong judgment and the ability to manage complex global programs and competing priorities. Willingness and ability to travel internationally and domestically, up to approximately 25% as required. Candidates must be authorized to work in the United States; sponsorship is not available for this position. Benefits Annual salary range of $135,000–$185,000 . Fully remote work arrangement. Opportunity to work on innovative NGS-based diagnostic and companion diagnostic products with global applications. Exposure to pharmaceutical partnerships, regulatory strategy, precision medicine, market access, and commercialization. Opportunity to collaborate with cross-functional teams spanning scientific, clinical, regulatory, commercial, and operational disciplines. Global industry and partner engagement, with travel of up to 25% as required. Inclusive workplace committed to equal employment opportunity and a diverse workforce.