Snr. Medical Director, Clinical Development - Neuro-Immunology

  • plaats

    Ghent, East Flanders

  • Sectoren:

    Life Sciences

  • soort baan:

    Blijvend

  • salaris:

    competitive benefits; short and long term incentives

  • Contact:

    Vladyslav Babych

  • Contact email:

    Vladyslav.Babych@volt.eu.com

  • functie ref:

    76119-PHARM-VLB_1593676802

  • gepubliceerd:

    1 maand geleden

  • Vervaldatum:

    2020-08-01

  • Begin datum:

    ASAP

Detailed Job Description
A cutting edge and well invested European Biotechnology company is currently advancing range of compounds into late development and is looking to bring on board new Medical Director to fulfil Global Development Leadership role for the priority compound.
Medical Director will have main responsibility for advancement of key program and will be involved in other projects in various stages of development. The role requires robust leadership ability in global clinical development and expertise in Neurology, Neuro-immunology and particularly rare CNS diseases (MMN, CIDP, MG)

The responsibilities will include but not limited to:
* Creation and development of a network of methodological Experts and KOLs Globally
* Cross functional management of project teams in matrix organisation, (clinical project managers, data managers, bio-statisticians)
* Providing scientific and medical Leadership (PhI- PhIII)
* Delivery and maintenance of the Clinical Development Plan that contains the strategic and scientific elements of clinical development to deliver a product with an optimal value that can be registered and commercialised
* Delivery of all aspects of the Clinical Development Plan including all clinical trials on time and on budget and according to the principles of Good Clinical Practice and applicable regulations
* Timely and high quality contribution to trial protocols, trial reports, investigator brochures and clinical documents for regulatory submissions
* Presenting the strategic, scientific, financial and operational aspects of clinical development or equivalent plan to internal and external review or advisory boards
* Presenting the compound, protocols and results at expert meetings, advisory boards, congresses, or to regulatory authorities
* Primary publications of studies in alignment with the publication strategy and in alignment with regulatory requirements
* Providing input in compound strategy, development and life cycle management
* Ensuring that all activities required for execution of the clinical or equivalent plan are tracked and followed up on.

Minimum Requirements:
* Medical degree with at least 10 years industry experience in international drug development;
* Extensive Neuro-Immunology or Rare CNS experience, Clinical Experience in Neurology is a plus;
* Clinical expertise as physician and/or Medical Lead in Global Development;
* Experience with phases I, II, III of development essential
* Ability to organise work in a structured way compatible with other activities in early and late clinical development
* Demonstrated scientific competence and innovative thinking and ability to view project at strategic level and plan development accordingly
* Ability to prioritise and manage complex tasks and adapt to changing project needs
* Excellent written and verbal communication skills and fluency in business English