Clinical Development Scientist

The Senior Clinical Development Scientist for the Ultrasound group will be responsible for developing, generating, and disseminating clinical and economic evidence ensuring innovation and transformation with best-in-class clinical evidence.

• 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 life cycle management.
• Drive execution ensuring quality and timeliness of clinical programs and/or trials to support critical regulatory requirements, being agile and responsive during the course of design, execution, and interpretation of trial data.
• Collaborate with investigators, IRBs/ECs, Regulatory Agencies, societies, and associations to support claims, reimbursement, health economic outcomes, and/or market access.
• Ensure appropriate preparation, interpretation, and dissemination of all evidence generated, including Clinical Study Reports (CSRs), Clinical Evaluation Reports (CERs), abstracts, peer-reviewed manuscripts, as assigned.
• Lead or support scientific discussions with regulatory agencies or notified bodies, including proposed clinical investigations; review the process of clinical evidence generated for marketing authorization, in line extensions, including during sponsor regulatory inspections.

• 7 years of experience in clinical research/development/real world evidence (RWE); scientific study design, strong scientific background, and experience with Artificial Intelligence algorithm clinical performance validation.
• Deep expertise including innovative clinical trial design, registries, quality improvement initiatives, and creation of data networks and working knowledge of biostatistics.
• Demonstrated working knowledge of GCP, FDA regulations, and EU-MDR regulations, and in-depth understanding of product development and associated design controls for medical devices.
• Strong writing skills to produce quality clinical documents, including final reports.
• Ability to write original scientific documentation such as clinical study reports, regulatory filings, investigator brochures, clinical evaluation reports, internal reports, and scientific publications.
• Medical or scientific education (MD or PhD).
• Ability to successfully perform the minimum Physical, Cognitive, and Environmental job requirements with or without accommodation for this clinical position.
• Self-directed with a strong work ethic, agile, and able to work in a purposeful environment.
• Ability to collaborate effectively and influence decision-making with various teams cross-functionally, as well as externally.
• Analytical thinking skills, with the ability to present statistical methods and results to a variety of audiences, especially non-statisticians.
• Ability to travel up to 15% (domestic and international) according to business needs.