Medical Director, Clinical Development - Dermatology

  • Location

    Ghent, East Flanders

  • Sector:

    Life Sciences

  • Job type:

    Blijvend

  • Salary:

    Negotiable

  • Contact:

    Vladyslav Babych

  • Contact email:

    Vladyslav.Babych@volt.eu.com

  • Job ref:

    75774-PHARM-VLB_1576261667

  • Published:

    12 maanden geleden

  • Expiry date:

    2020-01-12

  • Startdate:

    ASAP

*To design phase I, II, III, and IV study protocols and clinical development plans,
*In lines with overall development objectives ensure collaboration with different functional teams,
*provide medical scientific input and writing of clinical sections of IB, IND sections, regulatory briefing books,
*Medical review of clinical trial data and manage patient safety; reporting on trial data to safety and clinical boards
*preparation of strategy presentations, present, and discuss data with governance, external consultants, KOLs, and participate in F2F meetings with regulatory and Healthcare authorities around the world and with the FDA.
*To create and/or review study documents/plans, such as monitoring plan, data management plan, safety review plan, etc.
*To proactively identify clinical development risks and propose risk mitigations.
*To serve as medical monitor with significant responsibility for safety surveillance. *To oversee the planning and management of investigator meetings, advisory boards, and other scientific committees as required by the protocol.
*To participate in the selection of sites, CROs, and vendors
*Ensuring overall safety of the molecule and supports overall program safety reporting (e.g. Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents)
*Providing medical scientific input and writing of clinical sections of trial and program level regulatory documents (e.g. Investigators' Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities)

Minimum Requirements
Experience:
*Minimum 5 years in core Clinical Research and Development
*Experience in Pharmaceutical company or CRO organisation in relevant function (Clinical Development Physician)
*Line Management experience is a plus

Specific Professional Competencies:
*Excellent knowledge of Dermatology
*Strong knowledge of clinical development methodology.
*Deep understanding of the scientific and biostatistical data.
*Proven ability to provide strategic and medical oversight to phases I, II, III of global clinical trials.