Global Clinical Lead, Neurology

  • Location

    Germany

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    €120000 - €160000 per annum + bonus, relocation package

  • Contact:

    Vladyslav Babych

  • Contact email:

    Vladyslav.Babych@volt.eu.com

  • Job ref:

    70169-PHARM-VLB_1596715333

  • Published:

    3 months ago

  • Expiry date:

    2020-09-05

  • Startdate:

    Q4 2020


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 5 years industry experience in international drug development;
* Extensive neuro-muscular or neuro-immunology experience, Board certification in Neurology is a plus but not essential;
* 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