Senior Imaging Scientist, Fluorescence & Clinical Imaging

Intuitive Surgical, Inc. in; Sunnyvale (CA); Vor Ort; USD 158.000 - 268.000; Vollzeit

Zusammenfassung

Intuitive Surgical, Inc. in Sunnyvale, CA, is seeking a Sr Imaging Scientist to lead the scientific foundation of fluorescence imaging programs, bridging clinical studies and imaging systems across registrational programs.

The role emphasizes translating endpoints into defensible study designs and aligning detection performance with clinical data. The successful candidate will oversee imaging system characterization, collaborate with cross-functional teams, and contribute to regulatory

Qualifikationen

• PhD in biomedical optics, medical imaging, biomedical engineering, electrical engineering, medical physics, or a related field.

Aufgaben

• Define primary, key secondary, and exploratory endpoints for imaging agent trials, and develop the clinical and literature justification supporting their performance thresholds.
• Partner with pathologists, surgeons, and investigators on the interpretation of imaging data by having a solid understanding of surgical, radiologic, and pathologic workflows.
• Develop study operations manuals focused on correlative analysis between intraoperative imaging and histopathology, including specimen mapping and the criteria by which fluorescence signal is matched to pathologic outcome.
• Develop imaging charters and fluorescence assessment procedures, establishing objective protocol-defined read criteria and a defensible reference standard.
• Oversee blinded independent central image review and reader agreement analyses, and lead scientific review of imaging data infrastructure, including database design, eCRF build, and data quality ahead of database lock.
• Author imaging content for protocols, statistical analysis plans, briefing books, and clinical study reports, and maintain consistency of imaging and endpoint definitions across submission documents.
• Translate health authority feedback into study design and documentation, and assess the applicability of regulatory guidance and precedent approvals to imaging agent programs.
• Design and execute bench and phantom studies establishing limit of detection, linearity, and reproducibility, and develop tissue-mimicking models and fluorophore standards.

Kenntnisse

Biomedical imaging

Drug development

Imaging data analysis

Python

MATLAB

Regulatory understanding

Ausbildung

PhD in biomedical optics / medical imaging / biomedical engineering

Tools

Python

MATLAB

Jobbeschreibung

Intuitive Surgical, Inc. in Sunnyvale, CA, is seeking a Sr Imaging Scientist to lead the scientific foundation of fluorescence imaging programs, bridging clinical studies and imaging systems across registrational programs.

The role emphasizes translating endpoints into defensible study designs and aligning detection performance with clinical data. The successful candidate will oversee imaging system characterization, collaborate with cross-functional teams, and contribute to regulatory