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 organisation 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 organisation 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 optimising 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.

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

• Who You Are :You are an analytical, strategic thinker who thrives in a fast-paced, matrixed environment. You are passionate about customer and patient-centricity, and you excel at integrating multiple cross-functional perspectives into a unified clinical strategy.

Referenz Nr.: 925235
Rolle: Clinical Development Lead- Cardiovascular
Industrie: Pharma
Arbeitsort: Spain/Austria/UK
Pensum: 100%
Start Datum: ASAP
Dauer: 12++ Months with a possibility of extension
Bewerbungsfrist: 22/09/2026

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