Ghent, East Flanders
12 maanden geleden
*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 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.