Scientist, Study Management

Role Summary The study director represents the single point of study control with the ultimate responsibility for the overall scientific conduct of the study, from the conceptualization to the closure. Study director plans, sets up and manages in vitro/vivo studies in a cross-functional way and in accordance with regulatory guidelines; interprets robust data up to highest scientific standards and conducts studies in the context of product acceptance and risk assessment. Responsibilities To participate actively in the conceptualization of studies: training studies, short proof of concept studies, establishment of less complex methods, and standard toxicology studies (Genotox, CytoTox and OECD 28d/90d etc). To deliver timely high quality, well written study related documents: IACUC application, study plan, study report and all the amendments adhering to the GLP, NACLAR, AAALAC and 3Rs guidelines. Based on the scientific questions and objectives of the study, study director shall develop a detailed, well written study plan consulting similar already existing documents (e.g. study plans for the training or OECD studies) prior to the study start. Study director shall lead the development of new methods needed for the study, in consultation with a senior study director. To lead and manage the activities of the study team on a daily basis by providing input to the technical staff and ensuring that work is executed according to study plans and timelines; to coordinate the inputs and implement ad hoc requests for changes by scientific team and the quality assurance team; to regularly report (by preparing high quality presentations) and interpret the data to teams in across different affiliates and draw the overall conclusions from the study in consultation with a senior study director. To act as a deputy study director by providing necessary support to a study director for the activities mentioned above (the level of support depends on the experience of the incumbent). To plan and conduct studies using project management tools within the timelines and budget; anticipate variations and provide information about changes on a timely basis; liaise with procurement and coordinate ordering of supplies (i.e. animal order) To keep up to date with relevant scientific literature, present and participate in internal Journal Club sessions, participate (i.e. provide graphs, tables, and data) in the preparation of scientific articles and business cases in collaboration with colleagues from other affiliates. To participate in the development and maintenance of the quality management system through: keeping the SOP and work instruction library current and drafting new SOPs and WKIs based on company needs or advances in technology Requirement • PhD in life sciences, pharmacology, toxicology or other relevant fields • Minimum 3 years of work experience with experimental animals (preferably rodents), or equivalent experience in a regulatory/scientific environment • PC Skills: Excellent knowledge of Microsoft office, familiar with customized computer systems, excellent communication skills Profound understanding of animal testing principles and GLP guidelines, familiar with project management tools