Snr Medical Director, - Clinical Development (Dermatology)

  • Emplacement

    Barcelona

  • spécialité:

    Biotechnologie

  • Un salaire:

    relocation on offer

  • Contact:

    Vladyslav Babych

  • Email du contact:

    Vladyslav.Babych@volt.eu.com

  • Référence du poste:

    75637-PHARM-VLB_1574771775

  • Publié:

    Il y a sur 4 ans

  • Date d'expiration:

    2019-12-26

  • Date de début:

    asap

I am currently working with pharmaceutical company that is committed to develop and deliver to the market innovative treatment options for major and rare Dermatology Indications and Immunology TA. The company has built a substantial pipeline is currently looking to appoint a Global Clinical Lead and Snr. Clinical Lead to take up a responsibility for several compounds development lead projects strategically and medically from early phases into product registration. The role requires robust leadership ability in global clinical development through to market authorisation.
This position will suit a research or pharmaceutical physician who has an exceptional knowledge of Dermatology and Immunology TA.

Duties and Responsibilities: The responsibilities will include but not limited to:
* 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
* Board certification in Dermatology preferred. Alternative medical specialisation may be considered providing you have evidence of significant clinical and/or development experience in Dermatology
* Clinical expertise as physician and/or clinical trial investigator preferred
* Experience with phases I, II, III of development essential
* Capability 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