Basel, Basel, Switzerland
I am a seasoned Drug Metabolism and Pharmacokinetics (DMPK) professional with over twenty years of experience supporting small‑molecule drug development from discovery through registration. I specialize in the design and execution of drug metabolism studies—including non‑radiolabel approaches—to meet regulatory expectations such as FDA Safety Testing of Drug Metabolites and ICH M3(R2). My expertise includes the planning, oversight, and interpretation of human ADME studies, with hands-on experience managing multiple studies. I have contributed directly to global regulatory interactions by co-authoring briefing books and participating in scientific advice meetings with health authorities. I have supported several successful NDA submissions, serving as a co‑author of the non‑clinical dossiers for several approved and marketed therapies. Beyond my scientific contributions, I have experience in leading a team of drug metabolism scientists. I also have a strong track record of guiding DMPK strategy, mentoring scientists, and contributing to / leading collaborative initiatives across industry consortia.
My main accountabilities in this role include: - Leadership of a team of three scientists investigating the metabolism of drugs in development. - Acting as a representative for DMPK on global project teams, advising on pre-clinical activites and human ADME studies. - The planning (project management) and conduct of pre-clinical (in vitro and in vivo) and clinical (human ADME) studies. - Specialist expertise in early clinical metabolite profiling studies without radiolabel, utilizing technologies such as high resolution mass spectrometry and NMR. - The investigation and application of new technologies to enable drug metabolism studies. - Contributions to regulatory documents (e.g. investigator brochures and pre-clinical summaries for clinical trial applications, clinical trial protocols, pre-clinical tabulated summaries for new drug registration)
Role and responsibilities: Elucidation of metabolite structures using a variety of mass spectrometry techniques from pre clinical and clinical studies, evaluation and implementation of new MS and chromatography technologies, contributing to metabolism reports and study protocols, training and supporting junior staff, participation in department strategy meetings and also international matrix teams focused on chromatography technologies and their application
Role and responsabilities: Structural elucidation of unknown impurities and degradents in drug candidates, report writing, HPLC method development and collaboration with a NMR team to solve more complex structure elucidation issues.