Drug Development Program Management, Director

• Jun 2023 - Present

Team Lead Project Managers, Director

• Mar 2019 - Jan 2023

I was leading a team of highly skilled project managers and ensured all projects were appropriately staffed. I hired new members and supported the development of all members.I was part of the PMO leadership team and in this capacity I contributed to the departmental processess to support the development of the company's portfolio

Director, Project Management

• Jan 2014 - Mar 2019

Managing cross functional expert teams to prepare for first in human trials and beyond. Create development plans and execute with the team of experts. Lead the teams through governance decsions and involve all stakeholders. Manage alliance partners. In concrete, for one project, I managed a team that realized the first in human studies followed by a proof of concept study. We managed FDA, EMA interactions followed by the start of Phase 3. For another project we successfully completed a first in human study and together with an alliance partner prepared for a 900 patients Proof of Concept Study. Show less

Project Management Leader

• Nov 2011 - Dec 2013

Managing a cross functional team in the Post Marketing Phase of a novel Hepatitis C drug together with an Alliance partner. Creating the plans and ensured execution in several new patients populations. I actually prepared and executed the plans for a major Type2 variation after the results of a successfull phase 3 program Managing a cross functional team in the Post Marketing Phase of a novel Hepatitis C drug together with an Alliance partner. Creating the plans and ensured execution in several new patients populations. I actually prepared and executed the plans for a major Type2 variation after the results of a successfull phase 3 program

Clinical Program Leader

• Apr 2007 - Oct 2011

Co-Lead the clinical development team of a Hepatitis C compound together with the Medical Leader.Co-create the Phase 3 clinical development plan with an Alliance partner. This was a great success and within record time we could market INCIVO in Europe.

Clinical Trial Lead Manager

• Oct 2005 - Mar 2007

Managing and developing a group of clinical trial leaders and ensuring correct project staffing. Developed internal processes to smoothen the start up of clinical trials.

Clinical Trial Leader

• Jun 2003 - Sep 2005

End to End set up and management of clinical trials in line with the clinical development plan. Managing the internal team of expert together with the CRO team into high performing clinical trial teams.HIV proof of concept studies, DDI studies, pediatric study preparation

Clinical Trials Project Manager

• Mar 1994 - May 2003

In the very early days of IQVIA, I was the 4th employee in Belgium and became a CRA to manage a phase 3 osteoporosis trial in Belgium and the Netherlands. I had to learn all aspects of the CRA job and ICH-GCP very fast since the trial was extremely successfull with over 700 subjects in Benelux. For obvious reasons, the study was audited several times and with the necessary adjustment, there were no major concerns left. After 2 years I became Clinical Team manager and later a Clinical Trial Project manager, dealing with all aspects, including the client contact. Show less