Clinical Development Scientist - Medical Devices - scientific publications.

Notes from the manager: I need a PHD or MD candidate who has a scientist background - This is a requirement. I need someone who has worked in the medical device space who has designed studies for regulatory environments. Reporting protocols experience within this industry also required. US Regulations experience is required and China NPA would be highly desired. I am not looking for a candidate who is a medical writer.

Ultrasound, Senior 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.

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 life cycle management. Drive execution ensuring quality and timeliness of clinical programs and/or trials to support critical regulatory requirements, be agile and responsive during course of design, execution, and interpretation of trial data. Collaborate with investigators, IRBs/ECs, Regulatory Agencies, societies, and associations; and additionally, 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 process of clinical evidence generated for marketing authorization, in line extensions, including during sponsor regulatory inspections.

You are the right fit if: You have acquired 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. You have deep expertise including innovative clinical trial design, registries, quality improvement initiatives, and creation of data networks and working knowledge of biostatistics. Your skills include a demonstrated working knowledge of Google Cloud Platform, FDA regulations and EU-MDR regulations, and in-depth understanding of product development and associated design controls for medical devices. You have strong writing skills to product quality clinical documents, including final reports. Strong knowledge and experience with study design is also desired. You have an ability to write original scientific documentation such as clinical study reports, regulatory filings, investigator brochures, clinical evaluation reports, internal reports and scientific publications. You have a medical or scientific education (MD or PhD). You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Clinical position. You are self-directed with a strong work ethic, agile, and have an ability to work in a purposeful environment. You can collaborate effectively and influence decision making with various teams cross-functionally, as well as externally. You can think analytically, present statistical methods and results to a variety of audiences, especially non-statisticians. You can travel up to 15% (domestic and international) according to business needs.,