Clinical Affairs Project Manager

Robeaute; Paris; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Robeauté seeks a Clinical Affairs Project Manager to lead GLP preclinical and early clinical studies for a microrobotic brain platform. You will manage regulatory submissions (IDE/FDA), coordinate CROs, and collaborate with surgeons and the Head of Clinical to drive study design and reporting.

The role emphasizes cross-disciplinary teamwork, high scientific integrity, and effective communication in English, with French preferred. Open to candidates across EMEA, based in a suitable location.

Qualifications

• MD/PhD or equivalent work experience in relevant areas.
• At least 5 years experience in preparation and execution of clinical trials with medical devices, incl GLP and IDE.
• Experience with device testing in lab and clinical environments.
• Strong written and spoken English; French preferred.

Responsabilités

• Plan and coordinate GLP preclinical and clinical studies with surgeon collaborators.
• Prepare documentation for ethics committees and regulatory submissions (IDE, FDA).
• Contract clinical study sites and manage CRO selection/contracts.
• Oversee GLP preclinical and clinical study management and reporting.
• Collaborate with surgeons on study design and execution; data collection and reporting.
• Contribute to conferences, medical communications, and publication support.

Connaissances

English communication

Clinical trial coordination

Formation

MD or PhD in Life Sciences or Biomedical Engineering

Description du poste

Robeauté is redefining the future of brain therapies through the first microrobotic platform designed to navigate the human brain with unprecedented precision. This new generation of medical microrobots will be able to diagnose, treat, and monitor the brain from within, overcoming the persistent limitations in treating neurological diseases that affect more than one in three people worldwide.

Since its founding in 2017, Robeauté has filed more than 50 patent applications. We recently raised €27 million in a Series A round led by Plural, Cherry Ventures, Kindred Ventures, and Brainlab, fueling our next phase of growth.

The successful candidate must excel in an energetic, collaborative small team environment, be able to move seamlessly between medical and engineering cultures and have a commitment to high product quality and scientific integrity. A strong sense of shared responsibility and shared reward is required, as is the ability to make work fun and interesting.

The Clinical AffairsProject Manager has the responsibility of planning, organizing and executing theGLP preclinical and early clinical studieswith Robeauté’s robotic brain biopsy and local drug delivery device, including support of regulatory submissions for clinical studies across geographies, IDE submission to the FDA, reporting to Head of Clinical.

In particular, the Clinical AffairsProject Managerwill plan and coordinate the preclinical and clinical studies together with the Head of Clinical and surgeon collaborators. The responsibilities include:

• Preclinical and clinical study design (includingGLP animal studies and animal model exploration)
• Writing preclinical and clinical protocols
• Preparing documentation for submission to local Ethics Committees, competent authorities in various geographies including to the USFDA (IDE)
• Clinical study site contracting
• CRO selection and contracting, including management ofbothGLP preclinical studies and clinical studies.
• Communication and collaboration with surgeon KOLs on study design, protocols and their execution
• Data collection and data management after testing
• Writing of detailed reports after preclinical or clinical use based on the data collected.
• Planning and participation in conferences, medical scientific communication and publication support.

In parallel, the Clinical AffairsProject Manageris expected to gain detailed knowledge of the clinical applications of Robeauté’s device and connect with and curate surgeon relationships with the goal of growing the surgeon community with mutual respect.

The Clinical AffairsProject Managerwill collaborate with the technical team that designs hardware and software by giving feedback after any device use in a preclinical or clinical context, on the robot’s performance and in order to develop the platform’s performance with an eye for the global development of the platform.

Furthermore, the Clinical AffairsProjectManager will collaborate with Head of Clinical on Medical Affairs management, the representation of Robeauté’s platform at conferences, the creation of a publication pipeline and the medical scientific value communication within the surgeon community.

This role is open to candidates based in EMEA locations.

Qualifications:

• MD, Master’s or Ph.D. in a Life Sciences field, Biomedical Engineering and/or M.Eng. and equivalent work experience in relevant areas
• At least 5 years experience in preparation and execution of clinical trials with medical devices, includingpreclinical (GLP) and/or regulatory submissions (IDE preferred)and subsequent study execution.
• Device test experience in lab and clinical environments
• Good written, communication and documentation skills in English required and French preferred

Preferred:

• Good knowledge of anatomy and physiology and ability to relate to surgeons and the surgeon community
• Ability to communicate Robeauté's product and mission to the surgeon community
• Good ability and predisposition for teamwork as well as ability to work independently
• Strong interdisciplinary understanding of robotics, electronics and control