Director, Senior Director

  • 製薬(医療用医薬品)
  • 研究開発

経験内容

14 years in clinical development of pharmaceuticals and vaccines
Specialized in biomarker development and validation
Development o in-vitro diagnostic tests, companion diagnostics
Serology, immunoassays, cell assays, DNA-based technologies, infectious disease assays (PRNTs).
25 years in clinical laboratory, in vitro diagnostics, IVD regulations, validation, clinical performance

氏名・職歴の開示について

氏名:(開示前)

職歴:(開示前)


自己紹介

Biomarker professional in clinical development
o Clinical trials for drugs and vaccines (ICH-GCP)
o Biomarker strategy & processes for pharma and biotech
o Biomarker discovery platforms (metabolome, proteome, transcriptome…)
o Clinical & technical assay validation for regulatory submission (FDA/EMA)
o Clinical sample testing oversight and budgeting in CRO laboratories
o Phytotherapy and alternative medicinal product development
o Life-cycle management support for marketed products - new indications

Diagnostics specialist
o Evaluation of medical need for diagnostics
o Life style Biomarker diagnostics
o Clinical validation of diagnostics through clinical studies

Scientist, professor in clinical chemistry
o Scientific publications
o Investigator initiated trials
o Liaison to academic partners

Entrepreneurial support
o Professional project management
o Business development support for SME/start-up companies
o In-licensing evaluation, portfolio management
o Startup coaching in medtech and biotech
o Business-driven and product-oriented mindset
o Structural change management

職歴

開示前(決済前には開示されます)