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State • durham nc
Disease State Scientist
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BioFire Diagnostics, LLCDurham, North Carolina- serp_jobs.job_card.full_time
Description
The Disease State Scientist plays a pivotal role in helping to set the clinical research agenda. This role will take the lead on organizing evidence needs into a strategic plan and requires the proven ability to drive clinical research to its completion. This includes the ability to formulate a clinical research question, identify a range of possible experimental design approaches for answering that research question, and then work with other team members to generate an actionable plan to execute on the generation of the evidence. As a key medical and scientific leader, activities will include the design and review clinical studies in coordination with other team members, as well as ensuring effective planning within your area of expertise. In addition, this role will aid in the interpretation of study data and results as well as the preparation of manuscripts and other associated materials.
The position plays a central role in the generation of the clinical and patient outcomes evidence that demonstrates the medical value of our solutions.
You will provide medical and scientific guidance to the team executing the non-registrational study program, ensuring alignment with established standards. The Global Medical Scientist collaborates closely with cross-functional teams, including Clinical Research Scientists, Biostatistics / Data Management, Data Managers, and Medical Writers to generate impactful clinical evidence that supports the company's evidence strategy. This role is crucial in our commitment to scientific excellence and patient-centric approaches within the competitive global healthcare landscape.
Additionally, you will stay informed about the latest scientific advancements and regulatory changes, ensuring our clinical evidence generation remains innovative and relevant.
This position can also be located in St. Louis OR Salt Lake City.
Primary Duties :
- Maintain deep expertise in the scientific and research landscape within the designated area of focus, ensuring continuous advancement in knowledge.
- Strategically define and articulate evidence needs through collaborative engagement, aligning with clinical and business objectives.
- Critically evaluate and determine the most effective pathways and methodologies for robust evidence generation.
- Lead the development and refinement of company-sponsored and collaborative study synopses and collaborates on protocol development while conducting thorough reviews of Investigator-Initiated Research (IIR) proposals.
- Establish and oversee a systematic study evaluation and selection framework, ensuring effective governance and portfolio optimization.
- Conduct comprehensive medical literature reviews, maintaining a cutting-edge understanding of key therapeutic areas.
- Serve as a distinguished subject matter expert, engaging with external stakeholders at various management levels to guide study operations and optimize research scheduling.
- Cultivate and sustain a global network of Key Opinion Leaders (KOLs) and Investigators, fostering meaningful clinical research collaborations.
- Provide authoritative medical guidance to cross-functional teams, including biostatistics / data management, R&D, regulatory affairs, and marketing, driving strategic decision-making.
Education and Experience Required :
Knowledge, Skills & Abilities
1. Strong ability to communicate complex scientific information clearly and concisely, both in writing and verbally.
LI-US
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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 , or by dialing 711 for access to Telecommunications Relay Services (TRS).