Global Medical Affairs Scientist Immunoassay
Location: Durham, United States
Position Type: Unfixed Term
Job Function: Medical Affairs
A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.
Position Summary:
The mission of the Global Medical Affairs department is to advance the value of bioMérieux diagnostic solutions to improve patient outcomes and address unmet medical needs, through innovation and optimization, evidence generation and knowledge dissemination.
The Global Medical Affairs Scientist contributes to the design and execution of complex peri and post-commercial launch studies (PPLS) to generate evidence of the medical value of bioMérieux immuno-assay products. This position reports to the PPLS Director of Global Medical Affairs for Immuno-Assay.
In this context, the following activities will have to be performed for either company sponsored trials or investigator initiated trials:
Related to Study Design:
- Design, write, review concept/protocols for peri & post launch studies (PPLS) with a particular focus on Health Economics and Outcome Research (HEOR), epidemiology study or performance studies.
- Able to sum-up the literature on a particular field of interest to serve the clinical study design, and convince stakeholders about the appropriateness of the design.
Related to Study Management:
- Act as a project manager to lead a multidisciplinary team dedicated to the success of the clinical study, composed of Medical Advisor(s), Medical Scientist(s), Data-Scientist and other function as relevant.
- Prepare and update regularly the study budgets.
- Prepare and update the study schedule using project management software.
- Communicate effectively with investigators at each study site.
- Organize the study set up activities:
- Identify and qualify the study sites,
- Prepare the ethical/regulatory submissions required for the studies (IRB…) and legal documents,
- Identify and select CRO,
- Coordinates legal contracts, logistics and training needed to initiate and execute studies.
- Monitor the study :
- Initiate the sites and monitor the progress of the study with or without the support of a CRO,
- Review the data and report the intermediate and final results.
- Close the study:
- Write the report,
- Archive all study related documents.
- Anticipate and proactively mitigate challenges and risks to timely execution of studies.
Related to Dissemination of Evidences:
- Contribute to abstract, poster, and peer-reviewed journal publication of study results,
- Perform oral presentation of posters or study results.
Related to Departmental Activities:
- Anticipate and proactively mitigates challenges and risks to timely execution of studies,
- Committed to the continuous improvement of study management, compliance, due diligence and reporting processes,
- Contributes to transversal projects specific to medical affairs,
- Act as the main Global Medical Affairs point of contact for regional/local North American Medical Affairs team, ensuring the coordination of evidence generation effort in the area.
Studies and Experience:
- Advanced Degree (e.g. Master’s degree, PhD, PharmD, MD or equivalent),
- Advanced experience in managing clinical trials/outcomes or interventional studies for IVD or pharmaceutical drugs,
- At least 5-8 years of relevant experience in clinical research,
- Experience within Medical Affairs would be a strong asset.
Skills and Qualifications:
- Proficient in writing research protocols and scientific papers,
- Strong networking skills with key opinion leaders and principal investigators,
- Excellent interpersonal, analytical, communication (oral and written), presentation, and project management skills,
- Team player,
- Ability to work in a highly matrixed global environment,
- Strong prioritization and decision-making skills,
- Adaptable and flexible to adjust to changing demands, timelines and deliverables,
- Fluent in English.
Travel: 15% (domestic and international)
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 11,200 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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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).
