Clinical Microbiology Study Manager.
Affinity Biosensors (Santa Barbara, CA) has opened a full-time, high-impact position to design and monitor studies that validate the performance of its LifeScale rapid antibiotic susceptibility system.
Candidates should have extensive experience in microbiology R&D, study construction, and USFDA 510k clinical trials. Previous experience in microbiology laboratory research or study development, and/or commercial development of in-vitro diagnostic equipment pertaining to antibiotic susceptibility testing, is highly valued.
M.S. or Ph.D. degree in Microbiology or related field is required.
- Monitor ongoing clinical trials, including coordination with study monitor, communication with study sites, monitoring of study data and consumables
- Design protocols and monitor analytical studies in support of clinical trials
- Draft 510k pre-submission communications to the FDA for additional clinical trials
- Train laboratory staff on study protocols, in-house and at study sites
- Interact with engineering and quality systems groups
- Some travel required
- Detailed knowledge of microbiology lab function and clinical microbiology workflow
- Superior oral and written communication skills and leadership abilities
- Ability to thrive in a n multi-tasking, multi-disciplinary environment
- Critical thinking skills for advanced problem-solving
Affinity Biosensors offers competitive salaries and benefits, and opportunities for equity.