At a glanceSummarised by Seekless from the posting.
Must have4
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, including preclinical (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
Nice to have5
French 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
About the company
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.
Responsibilities
The Clinical Affairs Project Manager has the responsibility of planning, organizing and executing the GLP preclinical and early clinical studies with 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 Affairs Project Manager will plan and coordinate the preclinical and clinical studies together with the Head of Clinical and surgeon collaborators. The responsibilities include:
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Preclinical and clinical study design (including GLP animal studies and animal model exploration)
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Writing preclinical and clinical protocols
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Preparing documentation for submission to local Ethics Committees, competent authorities in various geographies including to the US FDA (IDE)
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Clinical study site contracting
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CRO selection and contracting, including management of both GLP preclinical studies and clinical studies.
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Communication and collaboration with surgeon KOLs on study design, protocols and their execution
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Data collection and data management after testing
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Writing of detailed reports after preclinical or clinical use based on the data collected.
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Planning and participation in conferences, medical scientific communication and publication support.
In parallel, the Clinical Affairs Project Manager is 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 Affairs Project Manager will 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 Affairs Project Manager 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.
Requirements
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, including preclinical (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:
Nice to have
•
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