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Hasnaà HADDOUK

VÉTRAZ-MONTHOUX

En résumé

With several years’ experience in R & D in Non Clinical Development within a Pharmaceutical biotech company and previously in a Contract Research Organisation (CRO), I have proven track records in managing teams and complex projects while liaising internally and externally with specialists and adding value as part of strong cross-functional team. At ease in dealing with communication of highly sensitive data and strong in assessment of benefit/risk analysis resulting in successful strategic decisions.

I have broad experience in toxicology, safety pharmacology and pharmacology for projects in preclinical and early clinical stage. My special interest in project management and regulatory affairs combined with these skills position me well to obtain successful regulatory submissions under challenging timelines that meet and exceed stakeholder expectations.

Entreprises

  • Consultant - Preclinical Development Specialist, PhD, ERT

    2013 - maintenant - Expertise in Non Clinical Safety
    - Advancement of lead molecules into clinical development
    - Gap analysis
    - Protocols, Data and Reports review ; IB preparation, Regulatory support
    - Project management
    - CRO selection and management

  • Addex Therapeutics - Director Non Clinical Safety

    2012 - 2013 - Responsible for Toxicology and pharmacokinetics activities until the FIH/PhIIa: strategy, design, planning and monitoring (virtual organisation with operational and scientific projects and CRO management)
    - Collection, preparation and review of the appropriate regulatory documents (for IND, CTA)
    - Coordination of activities with CMC, Clinical and Regulatory Affairs
    - Organisation of expert review (network of experts) and collaboration with academic Laboratories.
    - Actively involved in different projects as team member before and after clinical candidate selection and in due diligence process with potential partners.

  • Addex Therapeutics - Associate Director Non Clinical Safety

    2012 - 2012

  • Addex Pharmaceuticals - Group Leader in Non Clinical Safety

    2010 - 2011

  • Addex Pharmaceuticals - Laboratory Head in Non Clinical Safety

    2008 - 2010

  • CiToxLAB - Head of Genetic Toxicology and then Head of Short-Term and in vitro Toxicology

    Évreux 1996 - 2008

Formations

Pas de formation renseignée

Réseau

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