Clinical Development Scientist

Hybrid role in Bothell, WA or Cambridge, MA (3X/WEEK)

Clinical Development Scientist - 1 year long contract !

Requirements:

• An MD, PhD/MS Degree in Biomedical science with a scientist background
• 7 years’ experience in clinical research/development/real world evidence (RWE) function
• Strong scientific background in medical device space who has designed studies for regulatory environments (U.S. REGULATIONS REQUIRED)
• Experience in Machine Learning / Artificial Intelligence algorithm clinical performance validation

Day to Day:

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, 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.