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 510(k) 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 510(k) 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 multi-tasking, multi-disciplinary environment
· Critical thinking skills for advanced problem-solving
Affinity Biosensors offers competitive salaries and benefits, and opportunities for equity.
Job Type: Full-time