Dr. Ron Van Amsterdam

Ensure oversight and resourcing of project managers for the development of new drugs in therapeutic areas assigned (Nephrology and Urology); direct process and tools improvement as enablers; advise facility management and job grading across the organization. Achievements around cross-functional and cross-cultural collaboration, changing mindsets and driving automation/implementation of new tools.

Management of all assigned studies in the area of immunology and infectious diseases either directly or by managing the study managers. Authoring clinical study protocols. Authoring marketing application approval request modules 2.7.2, 2.7.3 and 2.5 on efficacy and benefit/risk. Worked in co-development projects and participated in multiple due diligence activities, a number having resulted in successful co-marketing of the assets.

Ensure the clinical development of recombinant human Complement 1 Inhibitor in Europe by creating a project team and study teams and driving studies as needed. Contribute to protocol and dossier development. Introduced the concept of a responsible Steering Committee consisting of engaged key opinion leaders, medics in the field.

Lead clinical development for all studies required to bring a long-acting anticoagulant to the market. Spot-on delivery of Proof of concept study and subsequent P3 confirmations across DVT, PE and Atrial Fibrillation applications. Co-authored study protocols and other documents required to obtain necessary approvals for study conduct. Member of Global Project Team as clinical researcher, medical scientist and pharmacologist.

Group lead in vascular pharmacology / pharmacologist responsible for preclinical profiling of peptidomimetics and synthetic carbohydrates potentially active in prevention and treatment of deep vein thrombosis and pulmonary embolism including STEMI and non-STEMI.

2-modules of 1 week each in months indicated, at Fontaine Bleau

Pulmonary allergy and hyperreactivity

Immunology, CNS Pharmacology, Rheumatology, Oncology