Clinical Development Lead – Freelancer

About the role

Lead the clinical development strategy for cardiovascular and metabolic diagnostic solutions, shaping the future of healthcare from a senior, strategic position within Roche Diagnostics Solutions in Vienna.

Key responsibilities

• Define and drive clinical strategy for large‑scale CVMD studies, including utility, intended use and claim extensions.
• Collaborate with Global Regulatory Affairs on international filing packages and review clinical documents for submissions.
• Act as medical lead with health authorities, build relationships with KOLs and manage development partnerships.
• Represent Roche at major medical congresses, advisory boards and in key publications.
• Champion innovation, IP strategy and optimisation of clinical processes.
• Coach and mentor team members, fostering skill development.

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 programmes.
• Deep understanding of global regulatory standards (ICH‑GCP, IVDD/IVDR, MDR, FDA, NMPA).

Required skills

• Clinical trial protocol design and report writing.
• Regulatory submission preparation and health‑authority interaction.
• Stakeholder partnership building with KOLs and academic institutions.