Product Manager – Global NGS Diagnostic Applications

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🕒 il y a 16 jours

🇺🇸 États-Unis – Télétravail

💵 $135 000 - $185 000 / an

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

✅ Responsable Produit

🗣️🇺🇸🇬🇧 Anglais requis

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Logo of 3T Biosciences

3T Biosciences

11 - 50 employés

Fondée en 2017

🧬 Biotechnologie

🏥 Santé

💊 Pharmaceutique

💰 €40 000 000 Series A en 2022-08

Biotechnology • Healthcare • Pharmaceuticals

3T est une entreprise d'immunothérapie qui développe des thérapies de nouvelle génération et transformatrices pour le traitement des tumeurs solides et d'autres maladies à médiation immunitaire chez de larges populations de patients. En tirant parti du pouvoir du système immunitaire pour reconnaître, cibler et détruire les cellules cancéreuses, la technologie de 3T fait progresser le développement de thérapies de nouvelle génération ayant le potentiel d'être plus sûres, plus efficaces et même curatives pour les cancers difficiles à traiter.

Description

• Support the development, launch, global commercialization, and lifecycle management of NGS-based diagnostic and companion diagnostic products • Define product strategy and align cross-functional and external stakeholders around molecular diagnostic solutions • Conduct market analysis, competitive assessments, and customer research across oncology diagnostics and NGS technologies • Define and maintain product requirements, target product profiles, application roadmaps, intended use, product claims, product naming, and value propositions • Prioritize features and manage trade-offs across technical, clinical, regulatory, operational, and commercial considerations • Partner with Regulatory Affairs and external regulatory partners on CDx classification strategy, submission planning, vendor/contract review, and consultation strategy • Partner with pharmaceutical collaborators and Alliance Management teams on product plans, clinical evidence strategies, regulatory pathways, and commercialization objectives • Lead market-by-market and global commercialization strategy and execution, including launch plans, readiness milestones, and lifecycle management • Support pricing strategy, reimbursement rate analysis, and financial/market-sizing modeling • Represent Product Management across project teams, governance forums, and partner committees • Monitor commercialization performance using KPIs and recommend corrective or growth actions • Lead customer-facing product discussions, 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 partners • Partner with Marketing, Sales, and Scientific Affairs to develop positioning, messaging, sales enablement tools, and training content

🎯 Exigences

• Bachelor's degree in molecular biology, genetics, biomedical engineering, bioinformatics, life sciences, or a related field required • 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, including FDA and at least one ex-US authority such as PMDA or EMA, in regulated diagnostic environments • 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, including library preparation, targeted sequencing, liquid biopsy, variant detection, and bioinformatics analysis • Familiarity with major sequencing platforms, including Illumina, Thermo Fisher, and Element Biosciences • Excellent communication, presentation, and organizational skills • Strategic, analytical, and customer-focused mindset with ability to influence cross-functional teams and external partners • Working knowledge of market access, reimbursement, pricing/transfer-pricing negotiation, demand forecasting, and financial or market-sizing analysis • Hands-on experience specifically with Illumina sequencing platforms, such as NextSeqDx and MiSeqDx • Ability to travel globally up to 25% as required • Pillar Biosciences is unable to provide sponsorship for this role

🏖️ Avantages

• Equal Opportunity employment commitment • Global travel opportunity of up to 25% (may be required)

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