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F. Hoffmann La Roche Gruppe
,
Welwyn Garden City, Hertfordshire
Medical Director, Respiratory and Allergic Diseases
Overview
We're looking for a candidate to fill this position in an exciting company Lead the clinical support across all relevant studies and support the Global Development Lead and overall team with cross-functional integration, coordination and alignment to enable effective clinical development execution. Maintain the highest standards and levels of scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment Act as medical monitor on clinical trials Monitor and review data Preparation of regulatory documents and interaction with global regulatory authorities Analysis, presentation and interpretation of studies and published data Interactions with health authorities and expert bodies Close collaboration with drug safety, regulatory affairs, medical affairs and clinical trial operations Participation in the preparation of abstracts, posters and presentations for scientific meetings and congresses Developing and writing clinical plans and protocols ensuring that they are scientifically sound M.D. with relevant fellowship training in Pulmonary/Respiratory. Candidates with 2 or more years pharma/biotech industry experience in Pulmonary who do not have fellowship training in Pulmonary will also be considered. Academic background is a plus. Experience working with the principles and techniques of data analysis, interpretation and clinical relevance. Versed in medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations.