Clinical Affairs Director – TX or Upper Midwest
Clinical Affairs Director will lead and manage the Clinical Affairs Department globally, reporting to the VP of R&D.
- PhD Molecular Biology/Biochemistry with 7 years clinical research experience, or MS with 10 years clinical research experience
- Clinical trials management experience leading to successful 510(k) and/or PMA submissions
- Minimum of 10 years’ experience in a GMP and/or FDA regulated environment
- 3 years International clinical trials experience
The Clinical Affairs Director will lead and manage a department globally. The main focus is the clinical validation of new in vitro diagnostic products. Will collaborate with Research, Regulatory, Scientific Affairs,and Sales & Marketing departments. Will ensure that the conduct of clinical research studies are in accordance with regulations and standards (e.g. 21 CFR part 812, CLSI, ICH, etc). Will also be responsible for the department’s administrative duties and the preparation and monitoring of the departmental fiscal year budget. Reports to the VP, R&D. Travel may be 20% of the time; International travel may be 10% of the time. Position may be at the office in TX or the upper Midwest.