Freelancer profile translated to English.

Description

Focusing on neuroscience, I led clinical strategy and study design at AZAFAROS B.V., enabling our team to develop innovative clinical protocols. My tenure as Head of Clinical Science strengthened my expertise, particularly in managing a clinical team and project budget.

At the helm of CView-Consult Gmbh, I leverage this expertise to guide study execution and skill development. Our mission is to transform clinical scientific knowledge into actionable strategies, ensuring treatments reach those in need effectively and efficiently.

Industry field of expertise

Languages

French
Native or bilingual

Workplace preferences

Can work on-site

Bâle (up to 50km)

Azafaros B.V.
Head of Clinical Science
February 2021 - August 2024 (3 years and 6 months)
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
January 2014 - January 2020 (6 years)
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
January 2013 - January 2014 (1 year)
• 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.