A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux provides diagnostic solutions that detect disease and contamination to improve patient health and ensure consumer safety. In North America we have more than 5,000 team members across 12 sites or subsidiaries, including Salt Lake City based BioFire Diagnostics. We believe in the power of diagnostics and bioMérieux sponsors public health initiatives and partnerships to address antimicrobial resistance, sepsis awareness, food safety, and consumer health across the globe. Come be a part of our mission to help save lives.
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 microbiology products (antimicrobial susceptibility testing, organism identification, blood culture systems). This position reports to the Director of Global Medical Affairs for Microbiology.
- Keeps abreast of scientific literature and recent developments in fields of clinical microbiology, in vitro diagnostics, and laboratory methods
- Synthesizes information from publications to establish a searchable database of evidence and identify gaps for the clinical microbiology portfolio
- Writes and reviews protocols to ensure sound study design and appropriate budget
- Communicates effectively with investigators at each study site
- Coordinates legal contracts, logistics and training needed to initiate and execute studies
- Plans and implements effective strategies for data management and 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
- Contributes to 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
- Coordinate laboratory related activities with R&D and Clinical Affairs if needed.
Studies, Experience, Skills and Qualifications:
- Advanced Degree (e.g. MS, PhD, PharmD or equivalent) with relevant experience in managing clinical trials/ studies in academic environment, clinical laboratory, healthcare, industry, or CRO
- At least 2-5 years of relevant experience in the areas of clinical microbiology, infectious diseases, and clinical research.
- Proficient in writing research protocols and scientific papers
- Familiar with microbiology laboratory test methods, regulatory standards, and practice guidelines
- Strong networking skills with key opinion leaders and principal investigators
- Excellent interpersonal, analytical, communication (oral and written), presentation, and project management skills
- Team player
- Ability to work in a highly matrixed global environment
- Strong prioritization and decision-making skills
- Fluent in English
- Travel: 15-20% (domestic and international)
- Location: St. Louis (MO) or Durham (NC)
Joining bioMérieux, is choosing to join an innovative company with a long term vision, committed to the service of public health and carried out with a humanistic corporate culture. Our Group offers numerous possibilities: so come and join the 13,000 bioMérieux team members who already identify with these values!
bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA.