Every immune system has a story to tell; the key is knowing how to listen.
Senior Director, Clinical Product Development
Location
United States
Posted
7 days ago
Salary
$206.4K - $309.6K / year
Job Description
Job Requirements
- PhD (or advanced degree) in molecular genetics, immunology, bioengineering or related field
- 10+ years of experience in a diagnostic, medical device or life sciences company
- Experience managing subordinate managers
- Minimum of 5 years of Product Development Process (PDP) experience with regulated IVD product development under design control, including verification and validation activities
- prior experience with NGS diagnostic product commercialization strongly preferred
- Demonstrated experience in ISO, CLIA, CAP, CLEP, FDA, IVDR, GxP or equivalent regulatory compliance requirements required
- Familiarity with the application of basic statistical analyses required
- Excellent technical scientific writing, communication, and organizational skills, with significant attention to detail
- Experience in hematology, oncology, immunology with NGS technology is preferred
- Prior experience with JMP, R or other statistical analysis software preferred.
Benefits
- equity grant
- bonus eligible
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