G lobal Medical Affairs Scientist

　　St. Louis, MO

　　The Global Medical Affairs Scientist contributes to the design and execution of peri-/ post-commercial launch studies (PPLS) and Health Economics and Outcome Research (HEOR) to generate evidence of the medical value of bioMérieux mi crobiology products ( antimicrobial susceptibility testing, organism identification, blood culture systems ) . This position reports to the Director of Global Medical Affairs for Microbiology.

　　Key Responsibilities

　　Keeps abreast of scientific literature and recent developments in fields of clinical microbiology, in-vitro diagnostics, and laboratory methods

　　S ynthesizes information from publications to establish a searchable database of evidence and identify gaps for the clinical microbiology portfolio

　　Design complex studies for assessment of health economic outcome , performance, and workflow efficiency of a single or combination of clinical microbiology platforms

　　Writes and reviews protocol s to ensure sound study design and appropriate budget

　　Communicates effectively with investigators at each study site

　　Coordinates legal contracts, logistics , and trainin g needed to initiate and execute stu dies

　　Plans and implements effective strategies for data management a nd statistical analysis

　　Anticipates and proactively mitigates challenges and risks to timely execution of studies

　　Monitors study progress and provides regular updates to the PPLS review board

　　C ontributes t o abstract, poster , and peer-reviewed journal publication of study results

　　Committed to the continuous improvement of study management , compliance, due diligence , and reporting processes

　　Contributes to transversal projects specific to medical affairs

　　Require d Education, Experience & Skills

　　Advanced Scientific degree plus relevant experience in clinical microbiology and man aging clinical trials in an academic environment, healthcare, industry, AND

　　At least 5 years of relevant experience in the areas of clinical microbiolog y (for example, antimicrobi al resistance, and sepsis ) and infectious diseases

　　Experience in health economic outcome research is highly desired

　　Experience with IVD regulations / international registration requirements is a plus

　　Proficient in writing research protocols and scientific papers

　　Deep familiarity with microbiology laboratory test methods, regulatory standards , and practice guidelines

　　S trong networking skills with key opinion leaders and principal investigators

　　Excellent interpersonal, analytical, communication (oral and written), presentation, and project management skills

　　T eam player

　　A bility to work in a highly matrixed global environment

　　Strong prioritization and decision-making skills

　　Travel: 15-20% ( domestic and international)

　　Location: St. Louis, MO