Product Manager - Global NGS Diagnostic Applications

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Product Manager - Global NGS Diagnostic Applications based in the United States.

This is a high-impact product leadership role focused on bringing innovative NGS-based diagnostic and companion diagnostic solutions to global markets.
You will shape product strategy from market insight and requirements definition through launch, commercialization, and lifecycle management.
The role sits at the intersection of molecular diagnostics, precision medicine, regulatory strategy, pharmaceutical partnerships, and commercial execution.
You will work closely with technical, clinical, regulatory, operational, marketing, sales, and external partner teams to move complex programs forward.
Your work will help translate advanced genomic technologies into clinically meaningful solutions that support better-informed healthcare decisions.
The environment is fast-paced, highly collaborative, and regulated, requiring strong judgment, strategic thinking, and exceptional stakeholder management.
Global travel of up to 25% may be required to support customers, partners, launches, and industry engagements.

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 au…