Product Manager - Global NGS Diagnostic Applications

Pillar Biosciences Incorporated; United States; Presencial; USD 135.000 - 185.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Travel opportunities

Competitive compensation

Descripción de la vacante

Pillar Biosciences, Inc. is seeking a dynamic Product Manager to lead the development, launch, and lifecycle management of next-generation sequencing (NGS)-based diagnostic and companion diagnostic products.

You will define product strategy, align stakeholders across clinical, regulatory, operational, and commercial functions, and drive global commercialization in a regulated diagnostics environment. The role requires strong communication, deep NGS knowledge, and a track record in global

Formación

• Minimum 5+ years in product management or commercialization of molecular diagnostics.
• Experience with companion diagnostics and global regulatory submissions.
• Strong knowledge of NGS workflows and Illumina platforms.
• Ability to lead cross-functional teams and external partnerships.

Responsabilidades

• Define product requirements, roadmaps, and value propositions for NGS-based diagnostics.
• Lead market-by-market commercialization plans with regulatory and reimbursement considerations.
• Collaborate with Regulatory Affairs and external partners on CDx classification and submissions.
• Coordinate cross-functional teams and governance for launch readiness and lifecycle management.
• Engage with laboratories, academic partners, and payers to support adoption and evidence generation.

Conocimientos

Product management

Commercialization

Molecular diagnostics

Genomics

NGS

Regulatory submissions

Global launches

Partnership programs

Cross-functional leadership

Communication

Educación

Bachelor's degree in molecular biology

Advanced degree preferred

Herramientas

NextSeqDx

MiSeqDx

Illumina sequencing

Descripción del empleo

Pillar Biosciences, Inc. is a pioneering precision medicine company focused on developing innovative diagnostic solutions that enable personalized healthcare. Pillar delivers accurate and efficient technologies that help clinicians, laboratories, researchers, and pharmaceutical partners translate complex molecular data into actionable insights across oncology, immunology, and other therapeutic areas.

We are seeking a dynamic and experienced Product Manager to support the development, launch, global commercialization, and lifecycle management of innovative next-generation sequencing (NGS)-based diagnostic and companion diagnostic products. The role is responsible for defining product strategy, aligning cross-functional and external stakeholders around clinically impactful molecular diagnostic solutions, managing product requirements, leading market-by-market commercialization planning, coordinating launch readiness, and representing Pillar externally with scientific, payer, and advocacy stakeholders. The ideal candidate combines strong communication skills and technical, regulatory, operational, and commercial acumen with the ability to lead complex global programs in a fast-paced regulated diagnostics environment.

Duties And Responsibilities

Market Insight & Product Definition

• Conduct market analysis, competitive assessments, and customer research across oncology diagnostics and NGS technologies, including monitoring incumbent or embedded competitor assays within partner programs, to inform differentiation and product positioning.
• Define and maintain product requirements, target product profiles, application roadmaps, intended use, product claims, product naming, and value propositions aligned with customer needs, clinical utility, and business objectives.
• Demonstrated ability to define product requirements, prioritize features, and manage trade-offs and cross-functional projects, stakeholders, and timelines across technical, clinical, regulatory, operational, and commercial considerations.

Regulatory & Pharma Partnership Engagement

• Partner directly with Regulatory Affairs and external regulatory partners (e.g., in-market MAH/DMAH representatives, regulatory consultants) on CDx classification strategy, submission planning, regulatory vendor/contract review, and consultation strategy across global jurisdictions.
• Partner with pharmaceutical collaborators and Alliance Management teams to align diagnostic product plans, clinical evidence generation strategies, regulatory pathways, and commercialization objectives for companion diagnostic programs.

Commercialization Strategy & Execution

• Lead market-by-market and global commercialization strategy and execution, including launch plans, market readiness milestones, and lifecycle management, accounting for regional regulatory, reimbursement, and pricing considerations and aligned with pharmaceutical partner timelines.
• Support pricing strategy, reimbursement rate analysis, and financial/market-sizing modeling (e.g., total addressable market, transfer pricing) to inform commercialization and launch decisions.

Cross-Functional Representation & Governance

• Serve as the primary Product Management representative across cross-functional project teams, governance forums, and partner committees, driving alignment, timely decision-making, and resolution of commercialization risks.
• Monitor commercialization performance using defined KPIs (e.g., launch readiness, site activation, customer adoption, market penetration, supply and lifecycle performance) and recommend corrective or growth actions.

External Partner & Stakeholder Collaboration

• Lead customer-facing product discussions in collaboration with Scientific Affairs, including scientific presentations, advisory boards, conferences, payer discussions, and advocacy engagement.
• Identify, evaluate, and govern Contract Laboratories, Centers of Excellence, reference laboratories, CROs, and other strategic testing or subcontracted partners, including oversight of confidentiality, quality, and performance obligations.
• Partner with Marketing, Sales, and Scientific Affairs to develop product positioning, messaging, launch and sales enablement tools, and training/educational content for laboratories, clinicians, and commercial teams.

Education & Qualifications

• Bachelor's degree in molecular biology, genetics, biomedical engineering, bioinformatics, life sciences, or a related field required; advanced degree (MS, MBA, PhD, or equivalent) preferred.
• 5+ years of product management or commercialization experience in molecular diagnostics, genomics, biotechnology, or pharmaceutical industry, supporting NGS or molecular diagnostic applications.
• 3+ years of direct experience with companion diagnostics, precision medicine applications, and pharmaceutical partnership programs.
• 3+ years of experience supporting global product launches or regulatory submissions across multiple jurisdictions (e.g., FDA and at least one ex-US authority such as PMDA or EMA) in regulated diagnostic environments, including developing commercialization and launch readiness plans.
• 3+ years of experience working with laboratory networks, CROs, Centers of Excellence, or decentralized testing models, including subcontractor governance and oversight.
• Strong understanding of NGS technologies and workflows (library preparation, targeted sequencing, liquid biopsy, variant detection, bioinformatics analysis), with familiarity across major sequencing platforms (e.g., Illumina, Thermo Fisher, Element Biosciences).
• Excellent communication, presentation, and organizational skills, with a strategic, analytical, customer-focused mindset and the ability to influence cross-functional teams and external partners (laboratories, pharmaceutical partners, payers, advocacy groups).
• Working knowledge of market access, reimbursement, pricing/transfer-pricing negotiation, demand forecasting, and financial or market-sizing analysis (e.g., TAM modeling, reimbursement code/rate analysis).
• Hands-on experience specifically with Illumina sequencing platforms (e.g., NextSeqDx, MiSeqDx).

Global travel up to 25% may be required.

$135,000 - $185,000 a year

Pillar Biosciences is an Equal Opportunity employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race, religion, age, nationality, marital status, sexual orientation, disability, or any other characteristic protected by law.

Please Note: Pillar Biosciences is unable to provide sponsorship for this role.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.