Clinical Development Lead

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. xiphteb

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

Referenz .: 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