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Medical Advisor/ Director, Global Medical Affairs - Microbiology

Employer
bioMérieux
Location
Durham, North Carolina, US
Salary
Competitive
Closing date
Jun 13, 2023

View more

Sector
Academic / Research
Field
Conservation science
Discipline
Project Management, Biology
Salary Type
Salary
Employment Type
Fellowship
Director of Global Medical Affairs (Microbiology)
The Director of Global Medical Affairs provides medical and scientific expertise to several departments and functions within bioMerieux. This position reports to the Vice President of Global Medical Affairs, Microbiology, Immunoassays, and Host Response and will be part of a team committed to optimizing patient outcomes by advancing the medical value of the bioMerieux microbiology portfolio (antimicrobial susceptibility testing, organism identification, blood culture systems).
Main Responsibilities

Provide medical and scientific guidance to R&D, Clinical & Regulatory Affairs, Marketing, and Commercial teams throughout the product life cycle (feasibility, development, clinical trials supporting registration, post-commercial launch) as well as for external opportunities and relevant due diligence
  • Develop and execute medical strategy and plan for the rapid AST, and blood culture product lines.
  • Act as an internal medical and clinical expert and provide inputs throughout the product development cycle.
  • Participate in health hazard and risk assessments, post-market surveillance, and field action board activities
  • Create and edit the medical and scientific content of documents and presentations
  • Review proposals for bioMérieux-initiated and investigator-initiated studies
  • Participate in planning, data analysis, and publication of outcomes research
  • Assist in training Medical Science Liaisons, Clinical Implementation Managers, and Medical Advisors
  • Gather medical insight through the continuous engagement of Key Opinion Leaders (KOLs) through scientific congresses, advisory boards, and other critical channels
  • Collaborate with regional and local Medical Affairs teams

Required Education, Experience & Skills

MD, PhD, PharmD with certification in Infectious Diseases or Clinical Pathology (Board Certification if medical training done in the USA) and fellowship or similar training in Medical or Clinical Microbiology
  • At least 7 years of relevant experience in the areas of infectious diseases, clinical microbiology, and clinical research
  • At least 3-5 years of experience as the director or associate director of clinical microbiology in the industry or laboratory settings
  • Comprehensive knowledge of antimicrobial susceptibility testing and blood culture management practices
  • Understanding of microbiology test methods, regulatory standards (CLIA, CAP, FDA), and clinical practice guidelines (CLSI, EUCAST, IDSA)
  • Excellent interpersonal, analytical, communication (oral and written), presentation, and project management skills
  • Evidence of scholarly achievement
  • Proficient in writing research protocols and scientific papers
  • Ability to collaborate across divisions in a highly matrixed environment
  • Strong prioritization and decision-making skills
  • Team player, flexible and adaptable
  • Fluent in English; fluency or high-level competency in an additional language is highly desirable

Travel 10-15%

Location: St. Louis (MO) or Durham (NC)

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