Position : Algorithms Validation Specialist
Location : San Francisco, CA - Hybrid(3 days a week Onsite)
Job Type : Contract
Job Responsibilities:
- Strong understanding of clinical imaging workflows and machine learning (ML) validation within the framework of Good Clinical Practices (GCP).
- Design and execute validation protocols for ML algorithms applied to imaging data (built by Data Scientists in the organization).
- Ensure compliance with GCP, FDA, and other relevant regulatory guidelines during algorithm testing and deployment.
- Maintain documentation for validation activities in accordance with GCP.
- Support audits and regulatory submissions by providing detailed validation reports to quality management teams.
- Work closely with data scientists, software engineers, and CRO’s to integrate validated ML models into clinical workflows.
- Strong communication and leadership skills to drive validation of algorithms with different stakeholders
Preferred Qualifications
- Strong understanding ML algorithms used in Radiology and Digital pathology area.
- Prior experience in validating ML algorithms with Pharma company.
- Prior experience of SaMD (Software as medical device) compliance of imaging software, ML algorithms used in reading radiology/pathological images.