Sr. Director Global Medical Affairs

Biomerieux Durham , NC 27701

Posted 3 months ago

Scientific and technological innovation is at the heart of bio

Mrieux's strategy. A world leader in the field of in vitro diagnostics for 50 years, bio

Mrieux designs, develops, produces, and markets diagnostic systems for medical and industrial applications. bio

Mrieux's solutions (reagents, instruments, software, and services) are used to determine the source of disease and contamination to improve patient health and ensure consumer safety.

To fulfill its mission to improve public health worldwide, bio

Mrieux is present in more than 150 countries through 41 subsidiaries. Its world headquarters are located in the Lyon area in France.

We are committed to creating an optimal work environment that fosters teamwork, emphasizes training and offers international career development opportunities.

bio

Merieux is an Equal Opportunity Employer/Affirmative Action Employer M/F/Vet/Disability/Sexual Orientation/Gender Identity

Global Medical / Scientific Affairs Sr. Global Medical Affairs Director (Microbiology)

The role of Sr. Global Medical Affairs Director is to lead the development and coordination of projects which provide medical and scientific expertise to several departments and functions globally for bio

Merieux. Activities will encompass the following areas:

Representation provide medical and scientific (microbiology, research, clinical laboratory experience) support to Commercial Operations; advise and assist interact with Key Opinion Leaders, clinicians, lab personnel and healthcare administrators; and assist with communications for and organization of symposia at scientific meetings and advisory boards.

Research provide input into in-house and investigator-initiated medical studies, and participate in health outcomes and economics studies. Assist in preparation of research grants. Can critically review and comment on proposed research studies.

R&D support product development as a scientific consultant to R&D programs to ensure that all relevant medical needs and requirements are addressed; Regulatory Affairs/Quality Affairs (RA/QA) provide medical and scientific expertise in the assessment and resolution of regulatory and quality issues.

Main Accountabilities:

  • Provide medical and scientific expertise in support of company microbiology initiatives.

  • Provide oversight and assist in the development and management of scientific advisory panels and scientific relationships, and provide technical expertise to the company including Marketing, R&D, bio

Mrieux Education.

  • Assist in the training of bio

Merieux Medical Science Liaisons (MSLs), Clinical Implementation Managers CIMs and Medical Advisors, as indicated

  • 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, Research and Marketing.

  • Support RA/QA in risk assessment.

  • Determine the impact of test results on clinical decision making and patient safety.

  • Help define, in coordination with programs and marketing, the need for medical and economic outcome studies to demonstrate clinical and economic value in support claims.

  • Assist team in providing medical references for the company

  • Attend congresses and other scientific meetings, sharing information with relevant stakeholders both internal and external to the company.

  • Assist in the planning and participate in company-sponsored scientific symposium

  • Research public scientific databases for background information

Knowledge/Skills:

  • MD, MD/PhD, PhD in Medical Microbiology with at least 7 years relevant experience in the areas of infectious diseases, clinical microbiology, diagnostics for infectious diseases, research and in vitro diagnostics clinical trials.

  • Knowledge of and experience in the operations of a clinical microbiology laboratory, current competitive testing methods, laboratory regulations (CLIA, CAP, JCAHO, CLSI, etc) is required.

  • Experience in industry is advantageous but not required.

  • Excellent knowledge of Microsoft, including PowerPoint , Word, Excel.

  • Excellent written and verbal communication skills

  • High level ability to research (PubMed), edit and write scientific papers, research protocols and grants

  • Strong interpersonal and diplomacy skills.

  • Creative problem-solving skills and decisiveness.

  • Project management skills.

  • Presentation and training skills.

  • Ability to create, motivate and work in a team environment.

  • Flexibility and adaptability

Travel 25-50% of time, national and international

Location: Durham NC (required)


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Sr. Director Global Medical Affairs

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