Clinical Development Lead- Cardiovascular: Clinical Strategy /Global Clinical Trials / Medical Device study management / ICH-GCP / IVDD/IVDR / MDR / FDA / NMPA /English
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 integral 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 while developing intellectual property strategies and optimizing clinical processes.
● Coach and Mentor: Act as a dedicated coach
📌 Clinical Development Lead (Comunidad de Madrid)
🏢 ITech Consult
📍 Comunidad de Madrid
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