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    Medical Director, Clinical Development, Neurology - Munich, Deutschland - ARTO

    ARTO
    ARTO Munich, Deutschland

    vor 3 Wochen

    Default job background
    Beschreibung

    Location: Germany

    About the Job

    ARTO is currently partnered with a global biotech company who are pursuing the development of multiple assets in the Neurology space. Specializing in small molecule therapies for chronic inflammatory and autoimmune diseases. As they approach phase III with their lead asset, they are looking to expand within their Medical team with the hiring of a (senior), Medical Director, Clinical Development.

    Medical Director, Neurology,

    The Role:

    • Creating and implementing the clinical development plan and the clinical strategy, whilst also providing medical input for development
    • Lead the preparation and completion of regulatory submission documents (NDA, IND) from submission to approval
    • Author and review protocols, safety data, clinical study reports
    • Provide Medical Expertise in meetings with regulatory agencies, advisory boards and external medical experts
    • Demonstrated experience in medical monitoring/data cleaning in clinical research or related industry

    Experience:

    • Preferred: Medical Doctor with a specialization in Neurology or neuro-inflammatory diseases
    • 5-10 Years of clinical drug development experience, (phase I to phase III) leading from initial study design, study execution and regulatory submissions (INDs, NDAs)
    • Competence in authoring and reviewing of critical scientific documentation (protocols, safety data, clinical study reports)
    • Hands on, motivated individual with the ability to work independently and as a team member to handle multiple tasks, including rapid response in review of information and documents

    If you'd like to learn more about this opportunity, please reach out and ill be happy to have a confidential discussion in more detail over the phone.

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