Pattern Bioscience
Diagnostics
Principal,Scientific&MedicalAffairs
“Principal, Scientific & Medical Affairs at Pattern Bioscience. Skills: clinical trials, GCP, FDA regulations, microbiology. Set up and support sites for clinical trials. providing training”
What You'll Achieve.
tackling antibiotic resistance; rapidly identifies bacterial infections; predicts the most effective antibiotics; prepare for and manage clinical studies; support external studies; Optimize clinical study workflows and implementation; Ensure studies are conducted, monitored, and documented; all errors are caught; queries appropriately resolved; Become familiar with Pattern technology and assay/instrument workflows; Perform site/data monitoring for clinical studies; Contribute to qualification of potential clinical study sites for upcoming studies; Help coordinate clinical specimen shipments from clinical partners to Pattern; Participate in Clinical Study preparedness activities; Participate in study site start up activities; Support Pneumonia ID/AST clinical study initiation at external sites; Organize Pneumonia ID/AST clinical study master files; Support set up and execution of analytical validation studies; Build relationships/credibility with other internal teams as well as external clinical sites/vendors; make a global impact
Industry & Context.
think nimbly; generate creative solutions
Average of 50% travel required, up to 75% travel during peak times
What They're Looking For.
Must Have
B.S. in biological sciences, medical laboratory science, or related field, 3-5 Years' experience in actively managing multi-site diagnostic device clinical trials, managing clinical study documentation/clinical study master files, Knowledge of GCP and FDA regulations related to conducting IVD/device clinical trials
Nice to Have
Hands-on lab experience in microbiology, applied knowledge of bacteriology, Experience working with clinical specimens and microorganisms, Working knowledge of general workflows in a clinical microbiology laboratory, Gram-stains, organism identification, conventional culture, AST, Knowledge and experience in performing and interpreting antibiotic susceptibility testing (AST)
What You'll Do.
Set up and support sites for clinical trials
maintaining close communication
organizing study documents
helping with study logistics
Optimize clinical study workflows
Ensure studies are conducted
Assist in the build and validation of electronic data capture systems
Review/monitor data from active external studies
Collaborate with Pattern’s R
How You'll Work.
Team & Collaboration
Serving as the liaison between clinical sites and Pattern teams; collaborate across the organization including with Assay Development, Hardware, Software, Quality, and Regulatory; Build relationships/credibility with other internal teams as well as external clinical sites/vendors
Communication Scope
communication skills
Process & Methodology
managing multi-site diagnostic device clinical trials, managing clinical study documentation/clinical study master files, Organize and maintain study documents and data files, Contribute to qualification of potential clinical study sites, Help coordinate clinical specimen shipments, Participate in Clinical Study preparedness activities, Participate in study site start up activities, Support Pneumonia ID/AST clinical study initiation, Organize Pneumonia ID/AST clinical study master files, Support set up and execution of analytical validation studies
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