Clinical Affairs Senior Manager Immunossays
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Location: Saint Louis, United States
Position Type: Unfixed Term
Job Function: Clinical Affairs
A world leader in the field of in vitro diagnostics for more than 60 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 6,200 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.
A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 45 countries and serve 160 countries with the support of a large distribution network.
Come and join a family-owned global company with a long-term vision, and a human-centered culture.
What are your responsibilities ?
Reporting to the Clinical Affairs Department, you will be responsible for the management of clinical studies for invitro diagnostic assays in the field of Immunoassays. You will manage a team in charge of designing, preparing and executing clinical studies on time and on budget.
Your main tasks will be to :
- Manage an international team (8 people US and France) and support them in the conduct of clinical studies from an operational point of view (on multiple sites at a global level) in compliance with regulatory and QA constraints,
- Promote functional excellence within your team, and optimize human and material resources,
- Contribute to the organization and management of the department's activities, in particular by participating in the preparation of the design budget and project timelines
- Contribute to process improvement initiatives within the overall department,
- Manage the interface with the Immunoassay franchise programs (e.g. R&D, program management, medical affairs).
What is your profile ?
Graduate degree in a scientific field with at least 10 years industry experience in Clinical Affairs management within IVD or pharmaceutical/health industry.
Experience with immunoassay point of care is desired.
You know how to work in project mode and have experience in coordinating the activities and interfaces required to bring a project to fruition.
You speak and write both French and English.
You are a self-starter with good teamwork and interpersonal skills. You are appreciated for your rigor and your oral and written expression skills.
bioMérieux welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at [email protected].
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).
