Strategic Clinical Development Lead – CVMD Diagnostics

F. Hoffmann-La Roche AG; Wien; Vor Ort; EUR 120.000 - 180.000; Vollzeit

Zusammenfassung

Roche Diagnostics Solutions (RDS) in Vienna is seeking a Clinical Development Lead for Cardiovascular and Metabolic diseases to shape clinical strategy and lead large-scale development programs. In this senior role you will partner with Regulatory Affairs, KOLs and cross‑functional teams to design studies, manage global submissions, and drive evidence generation for new diagnostics.

The ideal candidate holds an MD or PhD in a related field, with proven leadership in IVD/Medical Device trials and

Qualifikationen

• 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 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.

Aufgaben

• 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.

Kenntnisse

Analytical thinking

Strategic thinking

Cross-functional collaboration

Program leadership

Regulatory knowledge

Ausbildung

MD or PhD in cardiology/metabolic diseases/obesity or related fields

Jobbeschreibung

Roche Diagnostics Solutions (RDS) in Vienna is seeking a Clinical Development Lead for Cardiovascular and Metabolic diseases to shape clinical strategy and lead large-scale development programs. In this senior role you will partner with Regulatory Affairs, KOLs and cross‑functional teams to design studies, manage global submissions, and drive evidence generation for new diagnostics.

The ideal candidate holds an MD or PhD in a related field, with proven leadership in IVD/Medical Device trials and