Clinical Development Lead – Freelance (CVMD)

About the role

Roche Diagnostics Solutions is seeking a freelance Clinical Development Lead to drive the clinical strategy for cardiovascular and metabolic disease diagnostics. Based in Vienna, you will shape global clinical programs, interact with health authorities, and partner with key opinion leaders to bring innovative diagnostic solutions to patients.

Key responsibilities

• Lead the clinical development strategy for large‑scale CVMD studies, defining clinical utility, intended use and claim extensions.
• Collaborate with Global Regulatory Affairs to prepare and submit global regulatory filings, authoring meeting packages and reviewing clinical documents.
• Act as the medical lead in external interactions with health authorities and build strategic relationships with international KOLs.
• Oversee communication strategies for clinical studies, representing Roche at major medical congresses, advisory boards and key publications.
• Drive innovation, early pipeline activities and intellectual property strategies while optimizing clinical processes.
• Coach and mentor team members, fostering skill development and confidence.

Required profile

• Medical degree (MD) or PhD in cardiology, metabolic diseases, obesity or related fields.
• Established experience in academia, diagnostics or pharma within the CVMD area.
• Proven track record in IVD or medical device study management across global clinical trials.
• Demonstrated leadership of large, complex development programs and cross‑functional matrixed teams.
• Deep understanding of global standards and regulations (ICH‑GCP, IVDD/IVDR, MDR, FDA, NMPA).
• Ability to collaborate across diverse regions, cultures and time zones.

Required skills

• In Vitro Diagnostics (IVD) clinical trial design and execution.
• Regulatory knowledge: ICH‑GCP, IVDD/IVDR, MDR, FDA, NMPA.
• Clinical study protocol development and report writing.
• Stakeholder management with health authorities and KOLs.