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    Senior Clinical Pharmacometrician (m/f/d)

    from:
    medac is a dynamic company that has been growing continuously for over fifty years. More than 2,000 employees work on the further development of medical products and medical devices for the diagnosis and treatment of oncological, urological and autoimmune diseases. We are one of the leading pharmaceutical companies, in particular in the field of niche products.
    • Responsible for the planning and execution of relevant quantitative analyses which may include population pharmacokinetics, pharmacokinetics/ pharmacodynamics, exposure response, disease progression modeling, model-based meta-analysis as well as PBPK to support internal decision making and successful approval
    • Methodological input to establish/ confirm dose/ exposure-response relationship in target population
    • Contribute to design and analysis of studies into Food-Effects, Drug-Drug Interaction, QT/QTc
    • Writing/ review of PK/ PD sections of synopses, protocols, statistical analysis plans, interim PK reports in compliance with appropriate regulatory guidelines
    • Assessment of need for dose adjustment in special populations such as paediatrics, patients with renal and hepatic impairment, different races/ ethnicities
    • Methodological/ Statistical input to Biomarker identification, qualification/validation
    • Design of PK/PD-Bridging studies for extending our marketing authorizations to other countries, e.g. Japan
    • Contribute to efficient designs for bio-equivalence studies for medac’s generic pipeline
    • Co-author relevant documents such as clinical developmen plans, paediatrics investionational plans and CTD-documents.
    • Degree in Clinical Pharmacology, Pharmacy, Mathematics or Statistics with relevant experience in Pharmacometrics in the pharmaceutical industry, regulatory agencies, or academia
    • Profound Knowledge of clinical drug development and regulatory guidelines
    • Experience with M&S software
    • Ability to identify issues and solutions and to interact with internal and external bodies
    • Oral and written communication skills to interact in interdisciplinary teams
    • Fluency in written and spoken English and German


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