Sr Imaging Scientist

Intuitive•Sunnyvale, CA

13h•$158,200 - $267,900•Onsite

About The Position

The Sr. Scientist, Imaging Science is responsible for the technical and scientific foundation of Intuitive's fluorescence imaging programs, spanning the clinical studies that establish agent performance and the imaging systems that deliver it. The position is accountable for maintaining alignment between the detection performance established through system characterization and the performance measured in clinical study. The position requires depth across the full breadth of imaging science, from the definition and justification of clinical endpoints through the test methodology used to characterize imaging system and agent performance. Clinical development sits at the center of the position, bridging in two directions: toward Regulatory Affairs, where endpoints and imaging methodology must be defensible to health authorities, and toward Engineering, where the imaging systems of the future must resolve the imaging agents of today. The successful candidate will be equally effective in both. Near-term emphasis is on the scientific basis of Intuitive's registrational programs. As those study designs are finalized, responsibilities transition toward agent-device compatibility across current and future Intuitive platforms, ecosystem development, and computational tooling. The Principal Scientist partners with Clinical Development, Biostatistics, Regulatory Affairs, Imaging Systems Engineering, Software, Data Management, and external collaborators.

Requirements

PhD in biomedical optics, medical imaging, biomedical engineering, electrical engineering, medical physics, or a related field.
Minimum 5 years of drug development experience, including direct contribution to programs advancing through clinical development toward regulatory submission.
Demonstrated depth in optical or molecular imaging, including quantitative evaluation of detection performance against histopathology or an equivalent reference standard.
Hands-on experience characterizing imaging system performance, including phantom design, spectral measurement, and sensitivity or limit-of-detection testing.
Experience contributing to the design of clinical studies of imaging products, including endpoint definition and diagnostic performance measures.
Proficiency in diagnostic accuracy methodology, including sensitivity, specificity, predictive values, reference standard design, verification bias, and reader variability, together with the ability to critically review a statistical analysis plan.
Experience supporting regulatory activities, including authoring technical content for health authority submissions and meeting materials.
Working knowledge of the therapeutic and surgical context in which the agent is used, sufficient to evaluate whether a proposed endpoint is clinically meaningful.

Nice To Haves

Drug development experience overlapping with imaging hardware or device development.
Experience with fluorescence-guided surgery, near-infrared imaging, or endoscopic and robotic imaging platforms.
Familiarity with design controls and verification and validation processes.
Proficiency in Python, MATLAB, or equivalent for image analysis, and experience applying machine learning to medical image data.
Experience developing products in urologic oncology, urology, and/or genitourinary pathology therapeutic areas. Experience with prostatectomy preferred.

Responsibilities

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.
Prepare technical content for health authority meetings and submissions, and contribute to responses to Agency questions and information requests.
Translate health authority feedback into study design and documentation, and assess the applicability of regulatory guidance and precedent approvals to imaging agent programs.
Characterize agent performance on Intuitive platforms, including excitation and emission spectral matching, camera sensitivity, working distance, depth of detection, and signal-to-background ratio under clinically representative conditions.
Design and execute bench and phantom studies establishing limit of detection, linearity, and reproducibility, and develop the tissue-mimicking models and fluorophore standards those studies require.
Partner with Engineering and external collaborators on illumination, optical filter selection, sensor configuration, and display rendering, and define imaging system requirements for future platforms so next-generation systems can detect our agents.
Work with Software Engineering on image processing and visualization algorithms, and assess how software and firmware changes affect agent detection and the clinical interpretation of fluorescence.
Develop engineering test methods, protocols, and acceptance criteria, and contribute to design inputs, verification and validation, and design control documentation for agent-device combinations.
Develop computational and machine learning approaches that accelerate image analysis, system characterization, and development timelines.