Beschreibung

En me concentrant sur les neurosciences, j'ai dirigé la stratégie clinique et la conception des études chez AZAFAROS B.V., permettant à notre équipe de mettre au point des protocoles cliniques innovants. Mon mandat de responsable des sciences cliniques a renforcé mon expertise, en particulier dans la gestion d'une equipe clinique et la gestion budgetaire de projets.

À la tête de CView-Consult Gmbh, je mets à profit cette expertise pour guider l'exécution des études et le développement des compétences. Notre mission est de transformer les connaissances scientifiques cliniques en stratégies exploitables, en veillant à ce que les traitements parviennent à ceux qui en ont besoin de manière efficace et efficiente.

Branchenexpertise

Sprachen

Französisch
Muttersprachlich oder zweisprachig

Arbeitsortpräferenzen

Vor Ort möglich

Bâle (bis zu 50 km)

Azafaros B.V.
Head of Clinical Science
Februar 2021 - August 2024 (3 Jahre und 6 Monate)
Responsible for clinical development deliverables of a small molecule in Rare Disease (Lysosomal Storage Disorders). Lead and manage the multi-functional clinical team (~ 11 persons representing clinical operations, clinical sciences, clinical pharmacology and data management).
• Responsible for study design, execution (with budget control) and data interpretation of:
• Entry into human study, phase 1 in healthy volunteers.
• ADME phase 1 study and relative bioavailability study with food effect.
• Ongoing natural history study In GM1 and GM2 Gangliosidosis patients.
• Phase 2 clinical study In GM2 Gangliosidosis and Niemann pick type C patients (IND enabling study).
• Phase 3 clinical studies in GM1 , GM2 Gangliosidosis and Niemann Pick type C disease. Lead protocol development with health authorities' discussions and clinical experts' input. Provide strategic content for briefing documents for Type C and type A meeting request with FDA, scientific advice from CHMP and ILAP procedure with MHRA. Prepare answers and presentations for related meetings.
Roche Pharma
Principal Clinical Scientist Product development
Januar 2014 - Januar 2020 (6 Jahre)
Implementation of Real-world evidence studies supporting the qualification of smartphone app as software as medical device and digital endpoint.
• Responsible for protocol writing and studies set-up.
Novartis Ophthalmology
Clinical Scientist
Januar 2013 - Januar 2014 (1 Jahr)
• Support Medical lead with the development of program level documents in collaboration with development partner
• Lead development of concept sheet and protocol writing for phase 3 studies.