Clinical Trials Lead – Brain Robotics & GLP/IDE

Kindredventures; Paris; On-site; EUR 90,000 - 130,000; Full time

Job summary

Robeauté seeks a Clinical Affairs Project Manager to lead GLP preclinical and early clinical studies for robotic brain therapies. You will support regulatory submissions (IDE) and engage with surgeon collaborators across geographies, reporting to the Head of Clinical.

You will coordinate CROs, manage trial documentation, and help grow the surgeon community while ensuring high scientific integrity and cross-functional collaboration with hardware/software teams.

Qualifications

• MD, MSc or PhD in Life Sciences, Biomedical Engineering or related fields.
• Minimum 5 years of clinical trials experience with medical devices.
• Experience with GLP preclinical studies and regulatory submissions (IDE preferred).
• Fluent English; French preferred.

Responsibilities

• Plan and coordinate GLP preclinical and clinical studies.
• Prepare documentation for submission to Ethics Committees and authorities including FDA IDE.
• Clinical study site contracting and CRO management.
• Collaborate with surgeon KOLs on study design and execution.
• Data collection, management and reporting after studies.
• Feedback to hardware/software teams after device use to improve platform.
• Represent Robeauté at conferences and support publication pipeline.

Skills

Clinical coordination

Regulatory documentation

English communication

Education

MD/MSc/PhD in Life Sciences or Biomedical Engineering

Job description

Robeauté seeks a Clinical Affairs Project Manager to lead GLP preclinical and early clinical studies for robotic brain therapies. You will support regulatory submissions (IDE) and engage with surgeon collaborators across geographies, reporting to the Head of Clinical.

You will coordinate CROs, manage trial documentation, and help grow the surgeon community while ensuring high scientific integrity and cross-functional collaboration with hardware/software teams.