Professional Background

Gina has led and supported clinical trials across phases I–III, including site engagement, trial education, and patient recruitment and retention. She has directed European medical affairs strategy and execution for U.S. and EU companies, including pre-launch planning, launches, and post-launch evidence generation. As Founder and President of Blauwe Ara Medical Consultancy and former Medical Affairs Director Europe at Karyopharm Therapeutics, she has built EU medical affairs infrastructures for startups and helped establish their scientific presence in the region. Trained as a clinical pharmacologist and epidemiologist, she contributed to the development of the Dutch Children's Formulary to support rational, evidence-based prescribing in pediatrics and holds master's degrees in Medical Informatics and Pediatric Pharmaco-Epidemiology. Gina maintains an extensive network of European key opinion leaders, patient organizations, and regulatory stakeholders, is active in MAPS and the Accreditation Council for Medical Affairs, and is currently collaborating with ClinRM to support the expansion of its pharmacovigilance and medical affairs activities in Europe.

Core Expertise

• Drug safety and pharmacovigilance (local PV, EU QPPV experience)
• Medical affairs strategy, launch readiness, and post-marketing execution
• Clinical development support and clinical trial education
• Patient recruitment, retention, and site engagement across EU and ME
• KOL engagement, scientific communications, and stakeholder partnerships
• Multilingual communication (English, French, Spanish, Italian, Dutch)

Career Highlights

• Led a global program from preclinical studies through the 510(k) pathway and submission to German authorities for a novel wound-healing medical device.
• Supported global clinical trial operations, including investigator training, site selection, and development of centres of excellence across Europe.
• Directed EU medical affairs pre-launch and launch activities for phase II–III and marketed oncology products, including expanded access and quality-of-life initiatives.
• Served as local QPPV with experience in signal detection, risk communication, and safety reporting to European authorities.
• Established EU medical affairs landscapes and teams for multiple U.S. startups as the first employee in Europe.

Education & Clinical Training

• Clinical Pharmacologist and Clinical Epidemiologist — Erasmus University and NIHES, the Netherlands
• MSc in Pharmacoepidemiology — University of Bordeaux, France, and Erasmus University, Rotterdam, the Netherlands

Therapeutic Focus