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    Safety - United Kingdom - The RFT Group

    The RFT Group
    The RFT Group United Kingdom

    1 week ago

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    Description

    Head of Nonclinical SafetyOur client, a young Biotech company with an exciting pipeline, now have approval for a Nonclinical Expert role within their growing Clinical Science team.

    As a nonclinical expert you will be accountable for the design of the company's nonclinical safety and toxicology studies and implementation of planned studies with partner CRO's while meeting standards of excellence for ethics, scientific merit and regulatory compliance.

    This hire will be the interface with health authorities acting as the company toxicology representative and addresses questions in interactions with FDA, EMA and other authorities on nonclinical safety topics.

    Responsible for developing nonclinical safety strategies that support the clinical development plan.

    Responsible for planning and developing study designs, outsourcing partner management/consultants, oversight of operational activities, results reporting and review of analysis and interpretation.

    Consolidating safety data from nonclinical studies into key regulatory documents, such as Investigator's Brochures, briefing books, safety updates and submission dossiers.

    PhD or equivalent degree in the areas Toxicology or Pharmacology, with 10+ years related experience.
    Experience of toxicological risk assessment of impurities, extractables and leachables is beneficial but not essential.

    Demonstrates a broad knowledge in field of pharmaceutical toxicology and possesses knowledge of the relevant regulatory guidelines and preparation of submission documentation.

    Demonstrates good medical / scientific writing The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.

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