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Claude THEBAULT, MD

Bagneux

En résumé

Experienced International Pharmaceutical Physician in executive management of drug development (Phase I to IV) and Medical Affairs
Relevant experience in both R&D and medico-marketing with a solid track record in international medical information and global pharmacovigilance.
Big and mid pharmaceutical industries.
Team-player

European AFMPS Pharmacovigilance Agreement
Expertise in biometrics & IT tools
Ability to work at a local and global level


Specialties
R&D clinical & post-marketing development | Marketing support | Registration & Product launches | Pharmacovigilance | Medical Affairs | KOL management | Business development

Women's Health | Gynaecology & Obstetrics | Fertility | Rheumatology | Probiotics | Men's Health | Pulmonology | Gastroenterology | Sleep disorders | Oncology | Pain & inflammation and Vaccines

Mes compétences :
Pharmacovigilance

Entreprises

  • DBV Technologies - Medical Director, Food & Pediatric Allergies

    Bagneux 2012 - maintenant
  • Besins Healthcare - Medical Affairs Director, Hormonotherapy & Probiotics

    2006 - 2012 Provided decisive leadership and direction for Medical Affairs of company’s French Operation, with focus on guiding and supporting overall business and product strategies. Supervise, mentor, and coach 2 direct reports. Develop and implement initiatives to foster advocacy for company products. Build and manage strategic relationships with key opinion leaders, policy makers, healthcare professionals, and customer media outlets. Provide medical expertise, training, and support for corporate leaders, sales force, and product marketing teams. Skilfully represent corporate interests and serve as key scientific resource for external customers, stakeholders, conferences, and global media congress activities. Conduct medical evaluation of new opportunities targeting gynaecologic indications, and review presentation/marketing material content to ensure medical accuracy and compliance with industry and government regulations.
  • Roche Pharmaceuticals - Medical line manager Anemia, Oncology, Supportive Care

    2005 - 2006 Lead all medical activities in the Anemia and Oncology Supportive
    Medical team & Key products (PEGASYS (INN: peginterferon alfa-2a, NEORECORMON (INN: epoetin beta) management and performance improvement
  • Altana Pharma - Head of R&D, Pulmonology & Gastroenterology

    Paris 2002 - 2005 Primary leadership force of R&D Department operations and projects, providing executive leadership for team of up to 20 staff comprised of Study Managers, CRAs, and Study Assistants. Defined and directed strategic programme plans focused on compliance, patient safety, and efficacy, whilst promoting optimal results for corporate objectives. Coordinated and completed Phases II and III. Sourced, secured, and managed multiple vendors.
  • Aventis Pasteur - Vaccine Clinical Development Manager, Europe

    1999 - 2002 Held chief leadership and management accountability for Medical Affairs and European Clinical Development operations, defining and directing short-/long-term strategies to build and expand corporate vaccine drug portfolio. Supervised 7 team members and oversaw clinical research activities including 3 drugs in clinical development Phases IIIb and IV. Coordinated Clinical Trial Review Team, and performed strategic review of Investigator/post-marketing studies. Devised clinical development plans and produced medical information for marketing teams, shareholders, publications, and symposiums. Forged and managed KOL relationships.
  • Théraplix, Rhône-Poulenc Rorer - Head of Product Range & Pharmacovigilance, Hormones & Rheumatology

    1995 - 1999 Clinical development plan: Sleep disorders & Hormonotherapy/Rheumatology and Over-The-Counter medications with client services (patients & pharmacists) and distribution issues, commercial alignment with marketing people
    Management of Pharmacovigilance (Théraplix and Cooper)
  • Rhône-Poulenc Rorer - International Clinical Project Physician & Biostatistician Manager

    1990 - 1995 Socio-economic mission: epidemiology, incidence, prevalence, morbidity, mortality, risk factors, precision of the diagnosis, quality of life, medico-economic evaluation of asthma, choice of the competitors, clinical development plans [USA & Europe]
    Coordination clinical trials on migraine, rheumatoid arthritis and dental pain
    Investigator brochures, products monographs, writing of statistico-clinical reports, budget follow-up
    Management of team, head of 12 statisticians
    Responsible for the evaluation and production of statistico-clinical reports for the FDA TAXOTERE (INN: docetaxel) submission, phases I and II (23 clinical trials on Breast Cancer, Non-Small-Cell Lung cancer, Head and Neck Cancer)
  • Rhône-Poulenc Rorer - Biostatistician

    1990 - 1991 European launch of PROFENID IV (INN: ketoprofen), Pain & inflammation
    Analysis of clinical trials, protocol writing, statistical tools for assurance quality
    Design and production of protocols for various therapeutic areas

Formations

  • Université Strasbourg 1 Louis Pasteur

    Illkirch Graffenstaden 1997 - 1998 DIU

    Troubles du sommeil
  • Saint-Antoine Faculty Of Medicine (Paris Vi ())

    Paris Vi () 1995 - 1996 DU

    Methodology of the evaluation therapeutic risks
  • Medical UFR Kremlin-Bicêtre (Paris Xi)

    Paris Xi 1989 - 1990 Master’s Degree, Biological & Medical Sciences

    Data processing, Statistics and Epidemiology - C1 & C2: Statistics, Data processing and modelling; Methods in clinical and epidemiological research, Medical UFR Kremlin-Bicêtre, Paris XI
    C3: Therapeutic evaluation methodology, Medical UFR Broussais Hôtel-Dieu, P&M Curie
  • Necker-Enfants Malades University (Paris Vi ())

    Paris Vi () 1982 - 1990 Medical Doctor (MD) Degree

    Medicine

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