Switzerland
MD, board-certified specialist in Clinical Pharmacology with 10+ years of experience in clinical drug development within endocrinology, metabolism and rare disorders including hemophilia. Expertise in planning, designing, conducting, reporting clinical trials (phase 1-4), regulatory affairs and strategic development, including NDA/MAA Clinical submission with large clinical programmes and Health Authorities interactions (FDA, EMA, PMDA, MHRA, TGA). People leadership and pharmacovigilance experience, including both individual case follow-up and aggregate reporting (PBRER, DSUR, etc.).
Rare disease clinical development lead in Haemophilia early drug development projects.
Project and portfolio leadership across the diabetes and obesity pipeline, representing the Regional office in HQ. Responsible for clinical submission activities in Japan. Based in Tokyo, reporting to Global Development function in Denmark
Medical Lead for phase 1-4 clinical trials in rare diseases, including paediatric populations; Clinical submission and Q&A; leader of several cross-functional project teams; Medical oversight of all Pharmacovigilance strategy and activities; new assets strategy (due diligence) and development within rare genetic disorders of obesity: POMC/ PCSK1/LEPR deficiency, Bardet-Biedl syndrome.
Leader of a team of 7 Global Safety Surveillance Advisors (direct reports); key responder for HA-driven inspections and internal audits.
Strategic and medical leader of large clinical development programmes, focus on early stage: FHD, MAD and phase 2 design and conduct for new assets for several indications; Medical Project Lead supporting the Novo Nordisk Medical Centre of Expertise, organizing and chairing the cross-functional masterclass of clinical development, covering all stages of development across the value chain.
Design, planning, conduct, monitoring, and reporting of phase 1, 2, 3 and 4 clinical trials, including medical leadership for a large clinical submission for T2D: MAA/NDA to FDA, EMA and PMDA (Japan).