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Henk de Wilde, RPh
Partner & Managing Director, Europe

  • LinkedIn
  • 20 years industry experience with Roche, Switzerland (Clinical Operations, Oncology, Project Management, IT System Management, Quality Management, Vendor management)

  •  7 years with Pharma Bio-research in clinical pharmacology, CRO, ISO, GCP and GLP Certification (Netherlands)

  • 2 years in academic research in Microsurgery, Pain Management (Netherlands)

  • Business Process Optimization

  • Process Analysis and Re-engineering

  • Project and Clinical Trial Management

  • Trial Master File Management

  • Organizational Design

  • Quality by Design

  • Change Management

  • IT System Management

  • SOP Systems and Process Flow

  • Lead, designed and implemented a dedicated oncology focused matrix organization at major pharmaceutical company, successfully led the clinical development of a breast cancer compound supported various due diligence projects

  • Implemented a global safety distribution system to IRBs and investigators to ensure compliance with all global and local regulations

  • Lead and implemented a system for clinical trials and ensure compliance and completeness of trial registration for both registration and non-registration studies in over 90 countries

  • Lead the Clinical Project Management Function in a small CRO and large pharmaceutical company

  • Co-developed Informatics Landscape, identifying future business needs and the associated systems landscape for clinical development in a major pharmaceutical company

  • Re-engineered and implemented an SOP, business process and supporting system for Trial Master File management and aligned headquarters and affiliate organizations of major pharmaceutical company (>15,000pp) behind this critical compliance activity

  • Represented Clinical Operations in a number of major reorganizations/mergers and was responsible for the implementation of subsequent changes

  • Sponsored and/or lead multiple global business process re-engineering projects in Clinical Development, including clinical Trial Management, Safety Distribution and Resource Management

  • Mentor small start-up companies during first two years of development

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