2019 – 2023: Project Leader EU-SRS at aCBG

Responsible for the implementation of the European-wide substance database, called the EU Substance Registration System (EU-SRS). In EU-SRS, substances used in medicines are characterized in a scientifically sound manner, in line with ISO IDMP.

Responsibilities & Accomplishments

• Successful implementation of EU-SRS for use by the European regulatory authorities
  • Software implementation and validation
  • Data load, where EMA substances data were combined with FDA public data as well as newly created substances records
  • Handover of the hosting and maintenance of EU-SRS from BfArM to EMA
• Implementation of the Substances Validation Group (SVG)
  • Important achievement is the approval by the EU Heads of Medicines Agencies to install the SVG as the official HMA Working Group
• Publishing substances master data management guides for use by the SVG as well as EMA substances experts
• Drafting processes for substances data management, including defining triggers, the sources used, and how to collaborate between the SVG and EMA, as well as FDA. This applies to substances used in the human and veterinary domains
• Numerous presentations held to stakeholders to explain EU-SRS implementation project, the purpose of and the work done by the SVG

2012 - 2018: Development Project Management at Astellas

Astellas is a Japanese pharmaceutical company, with development headquarters in Tokyo and Chicago (also previously in Leiden). I started as Global Project Management Lead, being promoted to Director Project Management in 2015. I managed a team of PMs, in combination with running in-house projects.

Responsibilities & Accomplishments

• Global Development Project Manager
  • Urology – mirabegron (Type 2 variation, successfully filed to and approved by FDA)
  • Vasomotor symptoms – Fezolinetant – Post-merger integration lead after the acquisition of Ogeda, drug development strategy developed with project team
  • Nephrology – Roxadustat – ad interim Project Manager, co-development project
• Local Project Leader
  • Type 2 Diabetes – Suglat – A project to support filing the dossier by our Russian affiliate. The regulatory application was submitted to and approved by the Russian regulatory authority
• Regional Project Manager
  • Invasive Aspergillosis – Isavuconazole – The project was managed globally by colleagues in the US. My involvement was to ensure that the dossier for submission in Europe was prepared, including packaging and labelling. The dossier was submitted and approved in the EU.

1999 - 2012: Multiple supporting and management positions at Astellas

Responsibilities & Accomplishments

• Manager Project Management Office, including a 2-month secondment at Tokyo HQ
• Business Information Management, including:
  • Business intelligence
  • Management reporting
  • Performance management and metrics
• Software implementation and validation, including the Clinical Trials Management System
• Representing the Research & Development function in large company projects such as the implementation of SAP
• Management positions:
  • Head of Documentation Section
  • Manager Business Information Management
  • Team Lead Development Project Management

1996 - 1998: Data Manager at Hoechst Marion Roussel (Sanofi)

Responsibilities & Accomplishments

• Clinical Trials Database design, data cleaning, SAS programming for data consistency checks in clinical research
• Managing team of data entry (temp) staff
• 4-month secondment in Frankfurt to support the transition from a flat-file clinical studies database to an Oracle database. Acted as a liaison between end users and technical colleagues.