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Sobre esta vaga de Product Manager - Global NGS Diagnostic Applications na Pillarbiosciences

Pillarbiosciences · Remoto · Remote

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.


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.
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