medical professional with extensive experience in the Research and development of a specialist product portfolio within the Pharmaceutical Industry. strong communicator with the ability to lead and train key stakeholders in multi-product areas, providing Clinical and scientific support. resilient and commercially astute business Leader with the ability to mentor, manage and lead diverse teams to produce outstanding results. specialties: Clinical product Research and development with a demonstrable record of achievement and a firm understanding of the belgian Pharmaceuticals market. strong Leadership, man-management and Training expertise of multi-functional teams, with a firm commercial grasp of Business Development initiatives in line with strategic direction. excellent presentation, Negotiation, Communication and organizational skills. natural language fluency in dutch (native tongue), French and English.
Regional Head Pharmacovigilance Europe/Canada
Since April 2015
Medical Director Belgium and LuxemburgMarch 2012 --- April 2015
Founder and CEOJanuary 2000 --- December 2013
my own management company. co-established a management company with primary focus on the development of data collection projects for the Pharmaceutical Industry, with direct responsibility for 9 staff members. projects: 2001 - 2003: Co-founder, Associate and Business Development Manager for mxs bvba. management buyout of ixsys, due to a withdrawal of roularta medica. the entire team (9 fte) and all projects have been recuperated. the company is still active: see http://www.mxs.be for a list of projects. i left in 2003 to allow mxs to apply for projects from the belgian government including the army. 2000: Co-founder, Associate and Business Development Manager for ixsys nv, together with roularta medica belgium, rdsm nv and lotech bvba all projects above (novartis, cmpmedica and wyeth) are projects carried out as an independent contractor via medimacs.
AD Global Medical Education Manager Movement and Sleep DisordersNovember 2010 --- March 2012
Clinical Project Manager (CPM)July 2010 --- October 2010
TMF ReviewerJune 2010 --- July 2010
Interim project, outsourced by mediconsult bvba to astellas, to assist in an inspection readiness program. performing quality checks of trial master files.
Regional Medical MonitorFebruary 2009 --- June 2010
internally promoted due to prior experience and accomplishment, with responsibility for the research, development and successful launch of 2 major products within the field of hemophilia and one in the field of oncology; largely achieved forecasted target Sales within 12 months of initial launch. successful selection and acquisition of over 30 Hospitals in belgium and netherlands for participation in phase 1, 2, and 3 oncology studies and phase 4 hemophilia studies. key opinion Leader management in (hemato-) oncology in belgium and netherlands. discussions with investigators concerning study participation of patients in several drug trials, taking clinical decisions. answering medical questions from investigators. Training and Presentations for investigators and wyeth staff. handling and follow-up of serious adverse event reports. in collaboration with Project Manager: contract negotiations, supervision of site monitors, submissions to Ethics committees context: reporting to regional research Director benelux. part of regional Clinical research team and working closely together with 5 clinical project managers, about 20 CRA’s, 15 cta’s and 4 colleagues regional medical monitors. medically responsible for 13 Clinical trials in the benelux (4 products, 62 sites).
Medical AdvisorJune 2007 --- February 2009
directly reportable to the Medical Director and an integral key Member of 2 therapeutic area teams: oncology (1 Product Manager, 4 sales reps) hemophilia (1 Product Manager, 1 sales rep) responsible for the Training and Education of staff members in specific product areas, alongside providing medical and scientific advice. key success factors: start of the franchise oncology (internal and external Marketing) 2 compassionate use programs written and implemented successful launch of torisel in renal Cell Cancer communicating and managing emea’s negative opinion on mylotarg risk minimization plan for benefix reformulated successful launch of benefix reformulated successful launch of refacto af
Medical Information ConsultantJune 2005 --- June 2007
context: publisher of “artsenkrant, le journal du médecin” publisher of “belgian oncology news” editorial board member medibridge is a medical Software firm, owned by cmpmedica responsibilities: medical content creation and management e-publishing framework advice on ict management for medibridge key success factors: close view on the Market access Strategy of the newest products visiting congresses, interviewing kol’s in different areas improving writing skills with the support of the editorial team and the editor in chief
Medical AdvisorMay 2004 --- June 2005
context: first fte function in the industry reporting to the Medical Director belgium medical team of about 8 medical advisors responsibilities: Training and Education scientific advice kol management extensive Marketing support design of a framework to manage phase 4 observational studies key success factors: defending position and market share of the products Presentations for cardiologists and first line physicians introduction of the european guideline on human experiments into the daily management of observational studies development of a ict prototype to support study management
Medical Doctor - OfficerAugust 1988 --- April 2004
project lead, electronic medical record system from 2000 till 2004 military Physician taking care of belgian soldiers and there families located in germany from 1998-jan 2000 military Physician added to the 2nd battalion commando in flawinne (French speaking paratrooper unit) 1997-jan 1998 royal school of the medical component Medical Education at the civil University combined with an education as military officer. 1988-1996
in Informatics and Technology from in 2000
MD in from Vrije Universiteit Brussel in 1996
in from Koninklijke Kadettenschool in 1988