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 role of Global Medical Affairs VP (Molecular Biology) is to lead the development and coordination of projects which provide medical expertise to several departments and functions globally for bioMérieux. Activities will encompass the following areas, with a focus on all Molecular Biology based tests and platforms (nucleic acid extraction & amplification, genotypic characterization of pathogens, sequencing-based microbial identification and characterization, etc.):
- Representation and Education – provide medical and scientific (microbiology, research, clinical laboratory experience) support to Commercial Operations; advise, coordinate and assist with interactions with Key Opinion Leaders, subject matter experts, clinicians, lab personnel, healthcare administrators, public health personnel, and other healthcare providers; assist with content, communications and organization of symposia at scientific meetings; coordinate and support Molecular Biology assay and platform education in company programs.
- Research – coordinate and manage bioMérieux-initiated research (BIR) and investigator-initiated research (IIR) in the Peri- and Post-Launch Studies (PPLS) program, , including health outcomes and economics research (HEOR). Assist in preparation of research and funding grants submitted by the company. Critically review, analyze, comment on, and manage proposed real-world studies in the PPLS.
- R&D – support product development, internal and external innovation and product lifecycle management as a consultant to R&D programs and to Business Development group to ensure that all relevant medical needs and requirements are addressed; Regulatory Affairs/Quality Affairs (RA/QA) – provide medical expertise in the assessment and resolution of regulatory and quality issues.
- Provide medical expertise in support of company molecular biology and sequencing-based initiatives.
- Provide oversight and assist in the development and management of scientific and expert advisory boards and clinical relationships, and provide technical expertise to the company including Marketing, R&D, Business Development.
- Drive the global people strategy with an emphasis on attraction, retention, and building a diverse and inclusive funnel of future leaders.
- Create an organization that increases functional core competencies, scientific/technical rigor, productivity, and business impact.
- Assist in the training of bioMérieux Medical Science Liaisons (MSLs), Clinical Implementation Managers (CIMs) and Medical Advisors
- Assist in creation and coordination of external medical education in Molecular Biology as well as in Sequencing
- Help determine medical value of existing products and new product opportunities.
- Serve as scientific and medical consultant to program teams to enhance development of appropriate product requirements .
- Validate and/or expand product claims by interacting with Regulator Affairs, Clinical Affairs, R&D and Marketing.
- Support RA/QA in product risk assessments.
- Determine the impact of test results on clinical decision making and patient safety.
- Help define, in coordination with the product programs and Marketing, the need for medical and economic outcome PPLS to demonstrate clinical and economic value of products and solutions, and then implement and coordinate such real-world studies
- Assist team in providing medical references for the company
- Attend congresses and other scientific meetings, sharing information and networking with relevant stakeholders both internal and external to the company.
- Assist in the planning and participate in company-sponsored scientific symposium
Studies, Experience, Skills, and Qualifications:
- MD or PhD in Medical Microbiology or Clinical Microbiology /OR/ MD in Infectious Diseases /OR/ MD/PhD in a combination of the above fields
- At least 10 years relevant experience in the areas of infectious diseases, clinical microbiology, diagnostics for infectious diseases, research and in vitro diagnostics clinical trials.
- At least 10 years relevant experience in the fields of molecular biology and/or sequencing, some of which may overlap with relevant experience listed above
- Knowledge of and experience in the operations of a clinical microbiology laboratory, current competitive testing methods, laboratory regulations (CLIA, CAP, JCAHO, CLSI, EUCAST, other national and international bodies, etc) is required.
- Experience in industry is highly advantageous but not required.
- High level ability to research, edit and write scientific papers, research protocols and grant submissions
- Proven ability as a strategic leader that effectively prioritizes and leads/drives transformational change in a complex, large-scale matrix organization.
- Strong interpersonal skills and demonstrated ability to work effectively and collaboratively in a global (cross cultural) team environment
- Demonstrates strong conceptual thinking skills, quantitative and qualitative analytical and problem-solving skills, with strong business acumen.
- Ability to effectively deliver on complex situations or problems
- Project management skills.
- Presentation and training skills.
- Flexibility and adaptability
- Excellent written and verbal communication skills in English and at least one other major language
- Excellent knowledge of Microsoft Office Suite, including PowerPoint , Word, Excel.
- Travel 25-50% of time, national and international
- Location: USA (preferred): Salt Lake City UT (preferred) but there is some flexibility with respect to other USA locations such as Durham NC. Other USA locations might be considered.
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.