Über Ursula
Dynamic and results-oriented global leader with over 25 years of experience in Clinical and Medical Affairs in Medtech. Demonstrated expertise in clinical strategy development, clinical trial execution, and medical affairs across diverse therapeutic areas, including oncology, cardiology, diabetes, infectious diseases, cardiac imaging, osteoporosis and digital health. Proven track record of driving cross-functional teams and collaborations across diverse geographies to accelerate product innovation and market access. Optimizing clinical trial execution through the strategic application of AI, digital transformation, and Kaizen methodologies. Expert at coaching and building high-performing teams, fostering a culture of excellence and continuous improvement.
Französisch
Muttersprachlich oder zweisprachig
Englisch
Muttersprachlich oder zweisprachig
Niederländisch
Konversationssicher
Gujarati
Grundkenntnisse
Chinesisch
Grundkenntnisse
Vor Ort möglich
Brussels (bis zu 50 km)
Projekt- und Berufserfahrung
- Radiometer (Danaher)Global Senior Director Clinical and Medical AffairsJanuar 2024 - Januar 2025 (1 Jahr)Denmark• Led a team of 60 associates across multiple global locations (Denmark, Poland, Finland, France, India, China, US) overseeing Medical Affairs (Medical Advisors, MSL's), Clinical Operations (Clinical Study Managers, Clinical Program Managers, Clinical Scientific Leads), Clinical Surveillance (Clinical Surveillance Scientists, Medical Writers), Data Management and Biostatistics.• Managed the global clinical trials from strategy to execution, in line with business objectives and within set timelines and budget.• Optimized the planning, conduct and reporting of global clinical trials through AI and digitalization (Medidata eCRF, Veeva eTMS and CTMS).• Built solid collaboration with CRO's to support internal resources needs, with common governance process to monitor vendor performance, quality deliverables and budget.• Applied Kaizen DBS (Danaher Business System) tools (TPI, VPM) to:◦ Support operational excellence and continuous improvement◦ Drive cross functional accountability◦ Build integrated program timelines, deliverables and risk charter.• Fostered robust cross-functional and matrix collaborations with PMO support to establish effective program core teams, including R&D, Regulatory Affairs, Sales, Marketing, Legal, and Finance.• Strengthened the collaboration with Regulatory affairs leading to 4 FDA pre-sub meetings in 10 months, and shaped a global clinical strategy aligned across geographies to speed up the execution of pivotal clinical trials.• Expanded hospitals and KOL network by investing in the "future KOL generation".• Executed Medical Education programs/congress symposia: agenda development, faculty selection, review of presentations, faculty invitations and correspondence, and preparing the faculty for the event.• Developed a strong evidence roadmap through different channels: marketing and promotional material, publications, symposia, medical education programs.
- VANMOR ConsultingSenior Clinical and Medical Affairs Consultant, Co-founder of VANMORJanuar 2017 - Heute (9 Jahre und 5 Monate)Belgium• Successfully led business development activities leading to 50% revenue growth and strengthened strategic partnerships with innovation-driven startups.• Provide executive and Middle Management Leadership coaching specialized in the Healthcare sector.• Support sponsors in CRO selection and optimal integration with sponsor internal clinical teams.• Developed the post-market clinical follow-up strategy and led CRO selection for Sirtex (US), a medical device company providing SIRT treatment for HCC and MCC.(Interventional Oncology)• VP Clinical Affairs for Cryotherapeutics (BE), a startup developing a cryotherapy balloon to treat atherosclerotic disease in coronary arteries. (Cardiovascular)• Led the clinical strategy and operations for CardioRenal (FR), a digital health startup developing a decision support tool for heart failure patients. (Heart Failure, Telemedicine)• Designed the Clinical strategy and Clinical Development Plan for InhaTarget Therapeutics (BE), a startup developing a Cisplatin-based Dry Powder for Inhalation (solid-lipid microparticles) to treat Non-Small Cell Lung Cancer in combination with Standard of Care. (Oncology)• Provided strategic advice and developed clinical SOP's for CoreAalst (BE), an academic CRO and Core Lab focused on cardiac imaging.• Supported Medical Affairs activities for AgNovos, a startup pioneering a novel approach to treating patients with osteoporosis.• Led the clinical strategy and operations for Cardiawave (FR), a digital health startup developing non-invasive ultrasound therapy against calcific aortic stenosis. (Structural Heart)
- Grandpharma (part of China Grand Enterprises)Executive Director Clinical Affairs OverseasAugust 2021 - Januar 2024 (2 Jahre und 5 Monate)Belgium• Built the clinical strategy and supervised Clinical and Medical Affairs activities for all clinical programs sponsored by Grandpharma in Europe and US.• Provided strategic advice to Grandpharma sub-companies and closely tracked the progress of their evidence roadmap deliverables.• Supported due diligence activities, KOL network expansion and scientific collaborations with major universities in UK, Belgium, Australia and US. (Diabetes, Continuous Glucose Monitoring)
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Ausbildung und Abschlüsse
- International Coaching Federation (ICF) CertificationNOVATERRA2023International Coaching Federation (ICF) Certification
- Solvay Brussels School of Economics and Management2023