VP Clinical Affairs

🕒 il y a 3 jours

🏄 California, New Jersey, +1 états de plus – Distant

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

💵 $300 000 - $350 000 / an

⏰ Temps Plein

🔴 Expert

👔 Vice-président

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QuidelOrtho

Site WebLinkedInTous les Emplois

5001 - 10000 employés

⚕️ Assurance santé

💊 Pharmaceutique

🔬 Science

Healthcare Insurance • Pharmaceuticals • Science

QuidelOrtho est une entreprise mondiale axée sur la transformation des données de diagnostic en informations exploitables pour de meilleurs résultats de santé. Elle propose une large gamme de solutions de diagnostic, notamment des kits de test COVID-19 à domicile, des produits de chimie clinique, des produits immuno-dosage, des diagnostics moléculaires et des solutions automatisées pour les prestataires de soins de santé. Leurs produits sont conçus pour être utilisés dans divers environnements, de la maison à l'hôpital, du laboratoire à la clinique, afin de garantir des résultats de diagnostic fiables et rapides. QuidelOrtho vise à promouvoir un avenir plus sain en fournissant des informations exploitables en temps réel et une expertise de premier plan dans l'industrie.

Description

• 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

🎯 Exigences

• 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

🏖️ Avantages

• 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