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Clinical Affairs Manager

Location: Saint Louis, United States
Position Type: Unfixed Term
Job Function: Clinical Affairs

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.

Position Summary:

Based in Saint Louis MO, as a Clinical Affairs Manager, you will be responsible for the good execution of clinical trials aiming to validate the biological performance of our Microbiology Antibiotic Susceptibility Testing (AST) product lines (VITEK-2 in particular), according to Regulatory and Quality rules.

 

For this purpose, you will be supervising a group of Clinical Scientists in charge of conducting overall activities (including planning, initiation, execution and completion), following a process for the completion of clinical trials on time, within budget, to ultimately obtain the desired regulatory approvals, with a primary focus on CE mark, FDA and China registration expectations.

You will also be in charge of supervising post-launch activities which particularly consists in supporting the VITEK-2 program in the evaluation of the yearly published breakpoints. As part of these activities, you will also be supervising the support provided by the Clinical Scientists team to other projects (such as the implementation of new regulations), or provided to subsidiaries (advises on the design of local VITEK-2 clinical trials or revisit of VITEK-2 CA deliverables (data analysis, reporting…) to match with local and specific regulatory requirements).

 

Primacy Duties:

 

As a manager, you will also contribute to the global vision of Clinical Affairs Department and collaboratively lead and/or contribute to the following activities:

  • Enhance functional efficiency by forging cross-functional and global collaborations within the CA franchises at a global level (US + France), as well as external players including Program Management, R&D, Regulatory, Data Science, Commercial Operations and other key players.
  • Plan, allocate, and prioritize resources for effective conductance of departmental activities and operational performance.
  • Coach and assist in personal and overall team development (continuous learning and improvement) by identifying appropriate areas of development, networking and on-job performance enhancement.
  • Effectively communicate internally and externally by keeping CA management, team members and collaborators up to date on the departmental activities, action plans and achievement as necessary.
  • Develop clinical sites networking and set-up Master Trial/Service Agreement for anticipating further trials collaborations.

 

Position Requirements:

Bachelor's Degree, or Master's Degree in a scientific field with a clinical emphasis and expertise, MD/PharmD or equivalent.

8 to 10 years industry experience, ideally partially in the clinical research field, and including some experience in team management or project management.

 

Skills: Problem solving/Judgment, relationship building and multicultural ability, Innovation, Team leadership, Negotiating and influencing, Think out of the box mindset

 

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.

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