Principal Clinical Scientist at Genabio Diagnostics in Bedford, Massachusetts

Job Description:

1. Conducting site selection and qualification, Negotiating budget and contract with clinical sites.
2. Leading the development of clinical study protocol and reports.
3. Collaborating with Regulatory to prepare FDA pre-submission and submission packages.
4. Overseeing clinical sites, central lab, and other third parties to ensure issues are resolved timely.
5. Overseeing the clinical studies to ensure target timeline and budget are met.

1. A bachelor's degree or equivalent in a life sciences, nursing, or related discipline. Advance degree preferred.
2. Minimum 10 years of clinical research experience for medical device and IVD products. Minimum 5 years' experience with rapid self-test IVD products is required.
3. Experience in communicating with the FDA.