VP Clinical Affairs

🕒 Junho 3

🏄 California, New Jersey, +1 estados a mais – Remoto

🏄 California – Remote 🏖️ New Jersey – Remote 🗽 New York – Remote

💵 $300.000 - $350.000 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Vice-presidente

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QuidelOrtho

SiteLinkedInTodas as Vagas

5001 - 10000 funcionários

⚕️ Seguro de Saúde

💊 Farmacêutico

🔬 Ciência

Healthcare Insurance • Pharmaceuticals • Science

A QuidelOrtho é uma corporação global focada em transformar dados diagnósticos em insights acionáveis para gerar melhores desfechos em saúde. A empresa oferece uma ampla gama de soluções diagnósticas, incluindo kits de autoteste de COVID-19 para uso doméstico, química clínica, produtos de imunoensaio, diagnósticos moleculares e soluções automatizadas para prestadores de serviços de saúde. Seus produtos são projetados para uso em diversos ambientes — do lar ao hospital e do laboratório à clínica — garantindo resultados diagnósticos rápidos e confiáveis. A QuidelOrtho busca impulsionar um futuro mais saudável ao fornecer inteligência acionável em tempo real e expertise líder no setor.

Descrição

• Develop and execute the global clinical affairs strategy aligned to pipeline and growth objectives • Build integrated evidence-generation plans supporting FDA, IVDR, CE Mark, and international submissions • Serve as a trusted executive advisor on clinical trends, competitive dynamics, and market opportunities • Translate unmet customer needs from health systems, laboratories, and clinicians into actionable clinical priorities • Lead multicenter pivotal trials, performance studies, usability studies, and post-market evidence programs • Ensure high-quality execution across timelines, budgets, CRO management, and investigator relationships • Interpret clinical data to support claims development, product positioning, and launch readiness • Advance programs in respiratory disease, sepsis, bloodstream infection, antimicrobial stewardship, and emerging pathogens • Lead evidence strategies for troponin, BNP/NT-proBNP, coagulation, and cardiovascular risk diagnostics • Drive adoption strategies informed by real-world clinical laboratory operations and customer workflow needs • Build relationships with hospital labs, integrated delivery networks, academic centers, and reference laboratories • Collaborate with Medical Affairs to develop and implement publication strategy, advisory boards, and KOL engagement • Support market access and reimbursement evidence needs • Partner with Commercial teams on evidence-based messaging and customer education • Recruit, mentor, and retain top clinical affairs talent • Build scalable processes, metrics, and organizational capability to support growth • Foster a culture of urgency, accountability, collaboration, and excellence

🎯 Requisitos

• PhD preferred with 10-15+ years of progressive leadership experience in Clinical Affairs, Medical Affairs, or Clinical Research within IVD or medical diagnostics • Significant leadership experience within a top-tier diagnostics organization • Demonstrated success leading studies supporting major product launches and regulatory approvals • Experience across infectious disease, immunoassay, molecular diagnostics, cardiology, and/or core laboratory platforms • Proven people leadership with experience managing global teams and external partners • Deep understanding of FDA, IVDR, CLIA, CAP, GCP, and global diagnostics pathways • Strong knowledge of clinical laboratory operations, workflow optimization, quality systems, accreditation, and customer implementation challenges • Expertise in assay performance metrics, biomarker validation, and clinical utility evidence generation • Strong executive presence with ability to influence board-level and enterprise stakeholders • Commercial mindset with ability to connect clinical evidence to growth outcomes • Entrepreneurial leader who thrives in a fast-paced, high-accountability environment

🏖️ Benefícios

• medical, dental, vision, life, and disability insurance • 401(k) plan • employee assistance program • Employee Stock Purchase Plan • paid time off (including sick time) • paid Holidays