Anne De Wever

Senior Study Monitor Toxicology @ argenx

About

I’m a dedicated Project Manager in the pharmaceutical industry, passionate about Drug Development. I bring structure and focus to every project, while my enthusiasm and involvement energize cross-functional teams to achieve meaningful results together. I also bring over 20 years of nonclinical safety expertise, including GLP study oversight, PK/TK, and authoring regulatory submission content (IND, IMPD, CTD, IB). This combination bridges scientific detail and strategic execution, ensuring both data quality and program efficiency. I thrive on collaboration, continuous learning, and being closely engaged in every step of the process. For me, success is about delivering on time and budget and creating an environment where teams feel motivated and valued. Key Strengths: • Cross-functional program & project management (planning, timelines, budgets, risk management – Planisware) • Nonclinical safety & GLP study oversight (including PK/TK and toxicology risk assessment) • Cross-functional collaboration & stakeholder engagement • Problem solving, process improvement & knowledge sharing

Country

Belgium

City

Puurs

Industry

Pharmaceuticals

Skill

Project Coordination, Drug Development, Project Management, Project Planning, Cross-functional Collaborations, Toxicology, Biopharmaceuticals, Management, Planning Budgeting & Forecasting, Oncology, CART, Teamwork, Problem solving, Problem Solving, Life Sciences, Budget Management, Clinical Trials, Stakeholder Management, Business Process Improvement, Consultancy Services

Experience

Senior Study Monitor Toxicology

argenx

2026-2 - Present · 7 mos

Ghent, Flemish Region, Belgium

Functional Project Manager

Galapagos

2021-11 - 2025-3 · 3 yrs 5 mos

Mechelen, Flemish Region, Belgium

Held full development planning responsibility for the complete drug development process as a cross-functional project manager, including CMC, non-clinical, Clinical and regulatory stakeholders. Synchronized functional inputs, aligning resource allocation, and ensuring study deliverables were prepared to support clinical and regulatory objectives.

Functional Project Manager Regulatory

Galapagos

2020-10 - 2021-10 · 1 yr 1 mo

Mechelen, Flemish Region, Belgium

Consultant Non-Clinical Drug Development

Venn Life Sciences - part of hVIVO plc

2015-7 - 2020-9 · 5 yrs 3 mos

Breda Area, Netherlands

In this position I was responsible for non-clinical development activities for client projects, based on the most relevant and recent guidelines. These activities included the writing of drug development plans, CRO (Contract Research Organization) selection, monitoring of non-clinical studies, supporting reporting activities, writing regulatory documentation, etc. I participated in the drug development project teams, both internal and external.