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Dbv Technologies
- VP Clinical Operations
Bagneux
2015 - maintenant
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Middle-size Company
- Senior Medical Director
2011 - 2015
STALLERGENES
Specialized in Immunotherapy for allergic diseases
Responsible for the worldwide clinical development of a key immunology vaccine: clinical developments in Europe and North America (phase I to III), including submission of regulatory documents IMPD, CTA, PIP and IND, development of global clinical strategy.
Currently, launch of a large scale phase III pivotal worldwide study (EU, US, Canada, Russia, Israel... 165 centers, 2.000 patients).
In charge of preparation (briefing packages, slide presentations and preparation of clinical experts) and conduct of several scientific advice meetings and pre-submission meetings with EU and US authorities.
Key contact for our Japanese partner company developing one of our licensed products.
Main clinical contact for supporting the Marketing Authorization filing in Japan and Australia and to deal the questions on the clinical program from the Authorities.
Post Marketing Commitment studies design and negotiation with health authorities.
Main contact with Key Opinion Leaders in EU and US. Publications, abstracts and oral presentations in major scientific congresses.
Main Clinical Expert and Medical Affairs support for the launch of a first in class product.
Direct management of 2 clinical project teams (3-5 people), responsible of an annual budget of more than 15m EUR .
Internal clinical development expert role for several internal projects, in licensing and due diligences of external companies.
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SANOFI-AVENTIS
- International Clinical Head
2010 - 2011
Top 5 worldwide big-pharma company
In charge of driving the worldwide Clinical Development and life cycle management of a new hematology product, ensuring the optimal development of the strategy and plans, including business expansion. Biological product developed in Oncology and Orthopedic indications.
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Stallergenes
- Medical Director
ANTONY
2010 - 2015
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SANOFI AVENTIS
- Clinical Leader
Paris
2010 - 2011
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SERVIER
- International Project Director
Suresnes
2007 - 2010
Larger independent French pharmaceutical company - top 25 global pharma companies
Head of clinical development of a new major project in Cardiovascular area:
Direct management of a clinical team of 5 to 14 people + CROs
Functional management of a development team, involving all functions (Research, Regulatory, PV, Medical writing, strategic Marketing, various operation groups)
Main achievements:
* Successful management of a large international pivotal phase III clinical study: from initial protocol up to final clinical report, 29M EUR , 5.400 patients selected in 9 months, 92 centers, on time and on budget.
* Second phase III: study design, validation with R&D top management and initiation of the study of similar scale: 3.000 patients from 19 countries (incl. South and central America, Asia, Europe and North America). Coordination of 15 project teams from worldwide subsidiaries.
* Key clinical contact with a U.S. partner company for out-licensing one compound. Due diligence and preparation of the FDA dossier: pre-NDA file...
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BIOPROJET
- Head of Clinical Research
2005 - 2007
French Start-up Company - drug discovery and early clinical development
Head of the clinical research development program of a new pharmacological entity: (H3 Antagonist, new therapeutic class)
Definition and implementation of the clinical development program:
* 4 phase IIa studies in three CNS indications: Parkinson, Sleep Apnea and Narcolepsy.
* 1 phase III European study in Narcolepsy
Preparation and approval of an Orphan drug dossier to the EMEA,
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BOSTON SCIENTIFIC
- Clinical Research Manager
Nanterre Cedex
2003 - 2005
World leading medical device company - European Headquarter
European Clinical Research for Cardio-Vascular division and Operations Manager
Additional responsibilities in Cardiology and Vascular fields. Responsible of several European development programs with various innovative Medical Devices: TAXUS stent program, Filterwire, Cutting balloon, carotid stents ...
Integration of acquired start-up companies and bridging activities with internal teams.
Close relations with European Marketing teams to manage the EU clinical programs.
Head of Clinical Operations for 9 months, including reorganization the clinical monitor teams and processes.
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BOSTON SCIENTIFIC
- European Clinical Research Manager
Nanterre Cedex
2000 - 2003
World leading medical device company - European Headquarter
Responsible of 2 divisions: Gastroenterology, Oncology and Urology, representing approximately 1/3 of the European company turn over.
Design and implement the clinical /regulatory development plans in Europe for new products, in coordination with the US Headquarter (Natick, MA).
Managed up to 6 project leaders from the Clinical Department (Matrix cross divisional European team: German, Dutch, French and English)
Close relationship with European Key Opinion Leaders: leading member of scientific advisory boards organized by the divisions, support to scientific societies and Key Opinion Leaders' clinical programs (design and implementation of clinical projects), participation in National and International Congresses ...
Definition with the European Marketing groups, of the Market development strategy for the new launched products through: Life Cycle Management, Reimbursement strategy, Device Positioning activities.
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MEDPASS
- Medical Director & Head of Clinical Operations
1996 - 1999
Fast-growing French-American Contract Research Organization, specialized in European Medical Device development for U.S. stat-up companies. www.medpass.org/
Reports directly to the C.E.O.
Operational management: staff of 18 direct reports, including clinical and data-management project teams, allocation of resources, training and recruitment...
European regulation Advisor on product development for our US client companies.
Business development: expanded customer base mainly in the U.S. (80% of our clients), quotations of the clinical trials
Technical expertise: methodology expertise for our clients, Clinical Plan and Development Strategy, resolution of issues on the ongoing projects.
Main Accomplishments:
Development of the Clinical activities from 20% to 90% of the company turnover,
Reorganization of the clinical activities in Project Management Structure with Matrix Organization, definition of individual work performance policy
Development of a new time accounting system for the customers' billing, based on new standardized clinical activities quotation system
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Major French Contract Research Organization
- Senior International Project Leader
1995 - 1996
Pharmaceutical Development (+750 employees, 3 subsidiaries in
Management of several multinational phase III clinical trials in France and Europe (including Eastern countries), in Cardiology, Ophthalmology, Rheumatology, Gastro-Enterology for leading pharmaceutical companies: ROCHE, BOEHRINGER INGELHEIM, UCB PHARMA, ALLERGAN, SANOFI
Management of CRA teams (2 to 5) and one personal assistant,
Participation in internal SOPs development and ISO 9002 certification
Support to the business manager team for contract negotiations.
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CHAUVIN laboratory
- Medical Project Manager
1990 - 1995
French middle size pharmaceutical company specialized in Ophthalmology.
Manager of a clinical research unit (four people)
In charge of phase I, II and III clinical trials for French and European registration dossier of ophthalmology products.
Phase I: Safety studies and pharmacological tests in two phase I centers.
Phase II: Pharmacokinetic and dose/effect studies.
Phase III: Managed three multicenter clinical trials including two large European multicenter trials
Close contact with French and European ophthalmology key experts across Europe.
Therapeutic fields: 7 compounds developed in the fields of Inflammation, Glaucoma, Infection, AMD, Cataract... and new intra ocular lens (CE Marking)
Responsible for implementation of Standard Operating Procedures and European Good Clinical Practices in the Medical Department.
In house expert in Statistics: link with external consultant statisticians, good command of S.A.S. statistical software.
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University of Nice-Sophia-Antipolis - France
- Clinical Pharmacologist
1989 - 1990
Clinical Pharmacologist. University Clinical Pharmacology Department
Responsible for phase I clinical trials conducted in the Phase I center, part of the University Clinical Pharmacology department, Pr. LAPALUS (University of Nice-Sophia-Antipolis - France):
Design with Sponsors of key study documents: protocols, case report forms...
Conduct of the clinical studies as investigator (screening of healthy volunteers, data collection, medical follow-up)
Statistical analysis - clinical reports and publications writing
Scientific researches, in association with the researchers of the clinical pharmacology department (Pr. LAPALUS) and of IRIS PHARMA company (Dr. ELENA)
- Pharmacology: ocular and cardiac receptors, cell cultures... ;
- Pharmacokinetic and dose effect studies
