Ger Rikken serves as the Senior Director of Medical and Scientific Affairs at Asubio Pharmaceuticals, Inc., where he leverages over 25 years of extensive clinical research experience across a diverse range of therapeutic areas, including Respiratory, Allergy, Dermatology, Cardiology, Immunology, Infectious Diseases, Oncology, Urology, and...
Ger Rikken serves as the Senior Director of Medical and Scientific Affairs at Asubio Pharmaceuticals, Inc., where he leverages over 25 years of extensive clinical research experience across a diverse range of therapeutic areas, including Respiratory, Allergy, Dermatology, Cardiology, Immunology, Infectious Diseases, Oncology, Urology, and Neurology. In his current role, Ger is a pivotal global team leader for assigned compounds, guiding cross-functional teams through the complexities of clinical development from Phase I through Phase IV. His expertise in clinical pharmacology and regulatory submissions is instrumental in advancing innovative therapies from concept to market.
Ger's leadership extends to overseeing operational aspects, including the management of Contract Research Organizations (CROs), ensuring that studies are conducted in compliance with ICH-GCP guidelines. He plays a critical role in authoring Clinical Development Plans and is the clinical author for Phase I and Phase 2a proof-of-concept studies, where his strategic insights into study design have been vital for successful outcomes. His collaborative interactions with Preclinical and Chemistry, Manufacturing, and Controls (CMC) teams facilitate seamless product development, while his supervisory role as a subject-matter expert ensures that therapeutic area issues are addressed with precision.
In addition to his operational responsibilities, Ger is adept at preparing regulatory response documents, contributing to the successful navigation of the regulatory landscape. His multifaceted skill set encompasses not only clinical development and pharmacovigilance but also a deep understanding of both OTC and Rx-to-OTC switch processes. Ger Rikken's commitment to advancing medical science and improving patient outcomes is evident in his strategic approach to drug development and regulatory affairs at Asubio Pharmaceuticals.
