Clinical Development Lead- Cardiovascular

ITech Consult; Barcelona; Presencial; EUR 90.000 - 130.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Payroll-Only-Programm

Descripción de la vacante

ITech Consult is seeking a Clinical Development Lead, Cardiovascular, to shape the clinical strategy for large CVMD studies and global trials in diagnostics. You will collaborate with Regulatory Affairs for filings and engage with health authorities and KOLs to advance development programs.

The role requires extensive experience in IVD/Medical Device study management, cross-functional leadership, and regulatory knowledge across multiple regions, including travel up to 25%. Start ASAP.

Formación

• Proven experience in clinical development for diagnostics or medical devices.
• Strong understanding of global regulatory environments (ICH-GCP, IVDD/IVDR, MDR, FDA, NMPA).
• Experience leading large, complex development programs and matrixed teams.

Responsabilidades

• Lead clinical development strategy for large-scale CVMD studies and programs.
• Coordinate with Regulatory Affairs for global filings and submissions.
• Forge external partnerships with health authorities and KOLs.
• Oversee communication strategies for clinical studies and publications.
• Drive innovation while developing IP strategies and optimizing processes.
• Mentor and coach team members to build capabilities.

Conocimientos

ICH-GCP

Global regulatory filings

Cross-functional leadership

Strategic planning

Stakeholder management

Educación

MD

PhD

Cardiology/Metabolic diseases

Descripción del empleo

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

attraktives Payroll-Only-Programm: [phone].

Über uns

ITech Consult ist ein nach ISO 9001:2015 zertifiziertes Schweizer Unternehmen mit Niederlassungen in Deutschland und Irland. ITech Consult ist spezialisiert auf die Vermittlung von hochqualifizierten Kandidaten für den Personalverleih in den Bereichen, IT, Life Science & Engineering.

Wir bieten Personalverleih & Payroll Dienstleistungen an. Für unsere Kandidaten ist dies kostenlos, auch bei Payroll berechnen wir Ihnen keine zusätzlichen Gebühren.