Job Description
Salary: $90-95 hour/DOE
The Senior Clinical Development Scientist for the Ultrasound group will be responsible for developing, generating, and disseminating clinical and economic evidence to ensure innovation and transformation with best-in-class clinical evidence.
Your role:
* Contribute strategic guidance for clinical and economic evidence related to the end-to-end (E2E) development process from ideation through post-market for products in the Ultrasound business.
* Collaborate with key internal and external stakeholders to provide in-depth expertise to develop and lead clinical initiatives through non-clinical and clinical strategies for new product development initiatives and product lifecycle management.
* Drive execution ensuring quality and timeliness of clinical programs and trials to support regulatory requirements, and be agile during design, execution, and interpretation of trial data.
* Collaborate with investigators, IRBs/ECs, Regulatory Agencies, societies, and associations; support claims, reimbursement, health economic outcomes, and market access.
* Ensure proper preparation, interpretation, and dissemination of all evidence generated, including CSRs, CERs, abstracts, peer-reviewed manuscripts, as assigned.
* Lead or support scientific discussions with regulatory agencies, including review processes for clinical evidence for marketing authorization and line extensions, and during regulatory inspections.
You are the right fit if:
* You have 7+ years of experience in clinical research, development, or real-world evidence (RWE); scientific study design; and experience with AI algorithm clinical performance validation.
* You possess expertise in innovative clinical trial design, registries, quality improvement initiatives, and data networks, with knowledge of biostatistics.
* You have working knowledge of GCP, FDA regulations, EU-MDR regulations, and product development for medical devices.
* You have strong skills in writing clinical documents, including final reports.
* Study design experience is desired.
* You can produce scientific documentation such as clinical study reports, regulatory filings, investigator brochures, and scientific publications.
* You hold a medical or scientific degree (MD or PhD).
* You are self-directed, agile, and able to work effectively in a purposeful environment.
* You can collaborate and influence decision-making cross-functionally and externally.
* You can analyze data, present statistical methods and results to diverse audiences.
* Willingness to travel up to 15% domestically and internationally.
Benefits:
Paid sick leave, Medical/Dental (optional), 401(k) retirement plan (optional), employer-paid life insurance, short-term disability, optional life insurance.
ELYON International, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, national origin, age, disability, veteran status, or other protected categories.
#J-18808-Ljbffr