Descripción de la oferta
Clinical Development Lead- Cardiovascular: Clinical Strategy /Global Clinical Trials / Medical Device study management / ICH-GCP / IVDD/IVDR / MDR / FDA / NMPA /English
¿Tiene las siguientes habilidades, experiencia e impulso para tener éxito en este puesto? Descúbralo a continuación.
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 while developing intellectual property strategies and optimizing clinical processes.
Coach and Mentor: Act as a dedicated coach for team members, nurturing confidence and helping colleagues develop their skills and expertise.
Must Haves:
Medical degree (MD) or an advanced degree (PhD) in cardiology, metabolic diseases, obesity or related fields.
Established experience within academia, diagnostics, or the pharmaceutical industry, in the CVMD area.
Clinical Expertise: Proven track record in In Vitro Diagnostics (IVD) or Medical Device study management across all stages of global clinical trials, including protocol design and report writing.
Program Leadership: Demonstrated experience leading large, complex development programs and guiding cross-functional, matrixed teams.
Regulatory Knowledge: Deep understanding of applicable global standards and regulations, such as ICH-GCP, IVDD/IVDR, MDR, FDA, and NMPA.
Inclusion & Collaboration: Ability to partner effectively across diverse regions, cultures, and time zones to foster an environment of belonging and collaboration. xqysrnh
Travel: Willingness to travel up to 25% depending on project phases.
Referenz Nr.: 925235
Rolle: Clinical Development Lead- Cardiovascular
Industrie: Pharma
Work Location: Spain/Austria
Workload: 100%
Start Datum: ASAP
Duration: 12++ Months with a possibility of extension
Deadline : 22/09/2026
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