Clinical Development Lead

Clinical Development Lead- Cardiovascular: Clinical Strategy /Global Clinical Trials / Medical Device study management / ICH-GCP / IVDD/IVDR / MDR / FDA / NMPA /English

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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:

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• 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:

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• 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. xcskxlj
  
• Travel: Willingness to travel up to 25% depending on project phases.
  

Rolle: Clinical Development Lead- Cardiovascular

Work Location: Spain/Austria

Start Datum: ASAP

Duration: 12++ Months with a possibility of extension

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