Director, Clinical Affairs IVD

BioMerieux · Étoile-sur-Rhône

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A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For more than 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 46 countries and serve 160 countries with the support of a large distribution network.
Come and join a family-owned global company with a long-term vision, and a human-centered culture.

What are your main accountabilities?

Within Clinical Affairs, you will lead a team of Clinical Trial Managers (CTMs) and Clinical Research Associates (CRAs) responsible for the planning and execution of clinical performance studies in the In Vitro Diagnostics (IVD) field. You will ensure high-quality, compliant, and timely delivery of clinical studies, including international and multicenter studies, while contributing to continuous improvement and the broader Clinical Affairs strategy.

Key Responsibilities :

People Management & Leadership :

• Lead, coach, and develop a team of experienced CTMs and CRAs
• Set objectives, priorities, and resource allocation across clinical programs
• Foster accountability, collaboration, and professional development
• Drive change and influence decisions beyond your direct area of responsibility

Clinical Operations :

• Oversee the planning, initiation, monitoring, and close-out of IVD clinical performance studies
• Ensure study execution in compliance with protocols, internal procedures, quality standards, and applicable regulatory requirements
• Anticipate risks, resolve complex operational issues, and ensure timely study delivery.
• Oversee the quality, completeness, and traceability of clinical documentation and support regulatory submissions, audits, and inspections

Vendor & Cross-functional Management :

• Oversee the selection and performance of CROs, laboratories, logistics providers, and other external partners
• Supervise budgets and contract negotiations in collaboration with relevant functions
• Partner closely with Regulatory Affairs, Quality, R&D, Medical Affairs, Data Management/Biostatistics, and Project Management.

What is your profile ?

• Advanced scientific degree in life sciences, healthcare, or a related field
• Significant experience in Clinical Affairs or Clinical Operations within IVD or diagnostics
• Proven people management experience
• Strong experience managing international and multicenter clinical studies
• Solid knowledge of requirements applicable to IVD clinical performance studies, ideally within an IVDR environment
• Experience overseeing CROs/vendors, budgets, risks, and clinical documentation
• Strong leadership, influencing, problem-solving, and change-management skills
• Fluent English required.

bioMérieux welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

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