The Principal Pathologist is responsible for managing the clinical operations and the medical office of the company. The Principal Pathologist oversees the clinical division involved in validation of imaging applications, including oversight of studies leading to FDA 510(k) and PMA filings. The Principal Pathologist is a member of the Sunnyvale Management Team and will be jointly responsible for managing clinical collaborations for the company, including those with academic medical centers and reference laboratories. The Principal Pathologist develops research programs with key opinion leaders at these sites and works with internal business development along with R&D to execute these programs. The Principal Pathologist works closely with multiple other functions and groups, including Marketing, R&D, Quality and Regulatory to develop and review new products and applications as well as enhancing and refining existing products and applications and customer support for pathologist-related issues. The Principal Pathologist supervises the pathology requirements of the company, including image/slide review, test scoring, algorithm testing, algorithm validation, and application testing. Importantly, he or she will also represent Ventanas vision from a medical value and digital pathology perspective via preparation of abstracts and review articles, in meetings with external visiting pathologists, attend relevant scientific symposia, external pathology meetings and conferences.
– Oversight of FDA studies and filings
– Management of clinical collaborations
– Product/Application development and review
– Pathology supervision, including slide review/validation, tissue procurement, and application testing
– Presentations and Conference attendance
– Remain up to date on pathology, oncology and molecular biology literature related to Ventana's assay and imaging businesses
– Preparation of abstracts and peer reviewed publications
– Sales and Marketing support
– Customer support for pathologist-related issues
– M.D. Pathologist with American Board of pathology anatomic pathology board certification
– 5+ years of pathology training and practice
– 5+ years experience in biomedical research (PhD or other degree) or biotech/pharma industry
Knowledge, Skills, and Abilities:
– Diagnostic pathology
– Advanced staining and diagnostic methods including immunohistochemistry and in situ hybridization
– Familiarity with, and interest in, personalized medicine and companion diagnostics.
– Biomedical research and development
– Clinical study design
– FDA filings
– Demonstrated record of accomplishments (e.g. publications in scientific journals, issued US patents).
– Scientific writing and presentations
– Management experience
– Medical Informatics