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    Global Medical Lead - Berlin, Deutschland - Hydrogen Group

    Hydrogen Group
    Hydrogen Group Berlin, Deutschland

    vor 3 Wochen

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    Beschreibung

    Our client is looking for an MD with deep experience in Oncology clinical development to help drive their early clinical development pipeline in Oncology. Please see below for an outline of the position:

    Position Outline:

    • The Medical Lead (ML) is the main driver for the clinical development of individual pre-clinical/early clinical assets across various modalities and indications for Oncology. You will provide clinical-scientific leadership ensuring a medically and clinically sound development strategy for one or more global development programs (including due diligences) starting from pre-D1 up to Proof of Concept.
    • Depending on seniority and expertise, the Medical Lead can be nominated as a dedicated Expert, acting as a key representative for certain topics (i.e., functional expertise) or parts of the portfolio. In that role, he/she will be asked to both drive the respective topic from an overarching clinical point of view as well as represent it within and outside of the company.
    • In addition, the ML is a core member of Oncology (cross-)functional strategic initiatives above the individual program level in support of the overall Oncology strategy.

    Responsibilities:

    • Guide the preclinical evaluation and validation of new oncology assets in line with the overarching Oncology strategy focusing on value, differentiation, and unmet medical need.
    • Act as the clinical leader and single clinical representative for the global program(s) assigned to him/her and represents them both, internally and externally facing.
    • Drive and executes a clinically and medically sound development plan for the assigned assets with a focus on a definitive clinical experiment as well as an "end-to-end" mindset, which enables the collection of all relevant information for further seamless clinical development.
    • Be responsible for study medical/safety aspects and risk-benefit assessments supported by Pharmacovigilance and Clinical Trial Scientists.
    • Identify new opportunities for collaboration and manages relationships with new and existing internal and external partners within his/her assigned development program or internal/external workstreams.
    • Have sole responsibility for the development project, autonomously drive and execute a clinically and medically sound strategy with limited support needed from other peers; can be asked to support other MLs with clinical development expertise as well to mentor or deputize for those colleagues.
    • Push the boundaries of early drug development to accelerate and improve decision making, while continuously implementing the patient's perspective and ensuring patient's safety and benefit at all times.
    • Provide comprehensive knowledge of scientific, development, and regulatory landscape as well as clinical development methodology to enable state-of-the-art early precision drug development. Contribute deep disease specific knowledge within Oncology and can be asked to act as an expert representing an indication.
    • Contributes to Oncology-wide strategic initiatives

    Qualifications (Education, skills, experiences, and personal characteristics necessary for success in this position):

    • Medical excellence: M.D., M.D./PhD or equivalent degree and 5+ years in direct patient care; board certification within oncology/hematology or associated subspecialties is a plus
    • Solid experience in clinical drug development (Senior Medical Lead: 4+ years) as an academic investigator or within a pharmaceutical/biotech environment
    • Understanding of the scientific methods and tools used in early clinical development studies: biomarkers, translational modelling, biostats
    • Good understanding of Oncology medical needs and the clinical trial landscape
    • Understanding of basic science relevant to clinical oncology (biochemistry, immunology, molecular biology and/or genetics)
    • Experience with global health authority interactions. Participated and led a drug development program to registration or IND filling preferred
    • High energy with focus and vision; self-motivated with a high sense of ownership, urgency, proactive and solution-oriented, flexible entrepreneurial and open-minded approach to new and creative ideas

    Please submit your CV if you match the criteria and are interested in learning more about the role.

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