Clinical trials: manage regulatory aspects from protocol development to study completion, including reviewing cores submission documents (e.g., IB, protocol), preparing and submitting regulatory applications, coordinating interactions with regulatory authorities, and addressing queries. Additionally, collaborating with cross-functional teams to develop regulatory strategies aligned with project goals and timelines, while also monitoring changes in regulatory requirements to ensure ongoing compliance throughout the trial lifecycle.Scientific advice: facilitate interactions between pharmaceutical companies and regulatory agencies to seek guidance on various aspects of drug development, including pre-submission meetings to discuss development plans, study designs, endpoints, and regulatory requirements. Orphan Designation Application: facilitate the process of obtaining special status for products intended to treat rare diseases or conditions. This involves conducted thorough literature reviews and data analyses to support the application, highlighting the medical need and potential benefits of the product for patients with rare diseases, preparing orphan drug designation applications. Pediatric Investigation Plans (PIP): collaborate with team members to prepare the PIP application according to regulatory guidelines, ensuring completeness and accuracy.Regulatory intelligence: systematically gather, analyze, and interpret information about regulatory requirements, guidelines, and trends relevant to a specific industry or product.

Lead a cancer research team with 1 biologist, 2 doctoral candidates, and 1 technician.Manage 2-3 projects simultaneously, and guarantee timely delivery of the results (2-4 years duration) within the budget (€50.000- 300.000 per project). Coordinate internal as well as external partners by organizing meetings and exchanging emails.Keep up with the scientific advances, incorporating the knowledge with clinical need to write preclinical and clinical proposals (2 projects funded, in total 560.000 €). Review clinical and preclinical projects for Kom op tegen Kanker (KOTK) and Research Foundation Flanders (FWO) (more than 50 projects yearly). Complete the heavy workload and meet the deadline of reports and manuscript submission (5 publications).

Write preclinical and translational research proposals in seeking biomarkers and molecular targets in colorectal cancer (4 projects funded, in total € 630.000).Supervise undergraduate and graduate students to perform experiments, analyze data, and write the thesis.Compile and analyze research data for publication (3 publications). Design and execute experiments, and trouble-shooting in the course of research.