As Director of the Clinical Research group and Head of Activity, Gaëlle is leading the Clinical Research Team and related activities. This includes business development and contracts/budgets activities, marketing/external communication, training, quality assurance and knowledge management/ regulatory surveillance. Gaëlle provides expertise during public consultations on draft essential clinical trials regulatory documents as published by international regulators and overseeing VCLS readiness for the implementation of the EU- Clinical Trials Regulation.
In parallel, Gaëlle also leads clients’ projects in Clinical Research, providing strategic advice and regulatory oversight of clinical trials, managing submissions to competent authorities, ethics committees and other regulatory bodies both in Europe (directly) and in other regions (in collaboration with local partners). She also has responsibility for the review of core study documents, (e.g., protocol, investigator’s brochure [IB], labels and patient information leaflets – informed consent forms), together with the preparation and/or review of all other documents in accordance with local requirements.
Gaëlle is leading VCLS’s first Clinical Research Project under the EU-Clinical Trial Regulation and has therefore practical experience on its implementation.
She has experience with various types of products (drugs, biologics, advanced therapy medicinal products), therapeutic areas and trial phases, from first-in-human studies to confirmatory phase III trials.
Prior to joining VCLS, Gaëlle worked in the Biopharmaceutical Industry (Alexion), as a Worldwide Regulatory Strategist, in charge of clinical trial activities, clinical development plan, conduct of European and US scientific advice procedures including the authoring of briefing documents, orphan drug designation (ODD) applications, as well as in the preparation of Paediatric Investigation Plans (PIP).
Before that, she was employed by a large French Pharmaceutical company, gaining significant experience in clinical trials, post marketing activities in the US and Japan, and supporting the internal implementation of the EU pediatric regulation.
Gaëlle is a pharmacist by training and graduated in 2006 with a master’s degree in Pharmaceutical Regulation (Strasbourg – France),
In addition to French, her mother tongue, Gaëlle speaks English, and has a basic knowledge of German.
Gaëlle is based in Switzerland.