Clinical Development Lead- Cardiovascular: Clinical Strategy /General Clinical Trials / Medical Device study management / ICH-GCP / IVDD/IVDR / MDR / FDA / NMPA /English Los candidatos deben tomarse el tiempo de leer atentamente todos los elementos de este anuncio de empleo. Por favor, envíen su solicitud sin demora.
Background:
• Are you ready to shape the future of healthcare by leading the clinical development strategy for next generation diagnostic solutions? As a Clinical Development Lead, Cardiovascular and metabolic diseases (CVMD) within our Clinical and Medical Affairs organization in Diagnostics, you will play a pivotal role in planning and implementing clinical development activities that bring medically-differentiated solutions to patients globally. In this role, you will act as a senior strategic voice and trusted advisor, fostering an environment where science and collaboration thrive.
Key Responsibilities:
Drive Clinical Strategy: Lead the clinical development strategy for large-scale studies and complex programs, in the CVMD area, defining clinical utility,



intended use, and claim extensions across our portfolio.
Lead Health Authority Interactions: Work closely with Global Regulatory Affairs in the completion and submission of global regulatory filings, authoring critical sections of meeting packages and reviewing clinical documents for international regulatory submissions.
Forge Stakeholder Partnerships: Act as the medical lead in external interactions with health authorities, build strategic relationships with international Key Opinion Leaders (KOLs), and drive development partnerships across industry and academia.
Foster Communication Excellence: Oversee the implementation of communication strategies for clinical studies, representing the organization at major medical congresses, advisory boards, and in key publications.
Champion Innovation & Excellence: Act as a key driver for competitive differentiation, innovation, and early pipeline activities

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