A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety.
In North America we have more than 5,000 team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics and one subsidiary in Montreal, Canada.
Come and join a family-owned global company with a long-term vision, and a human-centered culture.
The Director of Global Medical Affairs leads the Peri- and Post- Launch Studies (PPLS) program and the team dedicated to generating medical value and Health Economics and Outcome Research (HEOR) evidence of bioMérieux’s microbiology portfolio (antimicrobial susceptibility testing, microbial identification, blood culture systems). The Director provides medical and scientific expertise to support the product life cycle in collaboration with various partners and stakeholders within bioMérieux. This position reports to the Vice President of Global Medical Affairs for Microbiology.
- Lead the overall management and operation of the PPLS program
- Manage the team of Medical Scientists responsible for leading or supervising the Investigator-Initiated Research (IIR), bioMérieux-Initiated Research (BIR), and collaborative studies
- Manage the budget and resource prioritization, allocation, and realization
- Develop and execute the global evidence gap plan and roadmap for microbiology portfolio and solution offerings
- Assure the successful planning and completion of studies resulting in timely publications and presentations
- Create and edit the medical and scientific content of documents and presentations
- Attend scientific meetings; assist in planning bioMérieux sponsored events; engage with external subject matter experts
- Collaborate closely with global and regional Medical Advisors located throughout the world to deliver the medical leadership
- Assist in training Medical Science Liaisons, Clinical Implementation Managers, and Medical Advisors as requested
- 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 as requested
- Participate in health hazard and risk assessments, post-market surveillance, and field action board activities as requested
- Drive the continuous improvement of study management, compliance, due diligence, and reporting processes
- Contribute to transversal projects across bioMérieux and those specific to Medical Affairs
- Assure quality reporting and communication within Medical Affairs and among the partners
Education and Experience
- Advanced degree (MD, PhD, PharmD, or DVM). Completion of an accredited fellowship or similar training in clinical microbiology is a plus
- At least 5-7 years of technical and people management experience working in a clinical microbiology laboratory or similar position in the industry in the areas of infectious diseases, clinical microbiology, and clinical research
- Experience in leading clinical outcomes and interventional studies is a plus
- Comprehensive knowledge of antimicrobial susceptibility testing, pathogen identification, and blood culture management is preferable
- Extensive experience in clinical study design, execution, monitoring, and completion
- Understanding of microbiology test methods, global regulatory standards (CLIA, CAP, FDA), and clinical practice guidelines (CLSI, EUCAST, IDSA) is a plus
- 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 globally and across divisions in a highly matrixed and cross-cultural environment
- Strong networking skills with key opinion leaders and principal investigators
- Strong prioritization and decision-making skills
- Team player, flexible, adaptable, growth mindset
- Fluent in English; fluency or high-level competency in an additional language is a plus
Travel: 15-20% (national and international)
Location: Durham, NC or St. Louis, MO (generous relocation package is available)
BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).