Principal, Scientific & Medical Affairs

Pattern Bioscience

19h•Onsite

About The Position

At Pattern Bioscience, we’re tackling antibiotic resistance, one of the biggest public health challenges of our time. Our technology rapidly identifies bacterial infections and predicts the most effective antibiotics to treat the infection. We’re building direct-from-specimen phenotypic rapid organism identification/antimicrobial susceptibility testing (ID/AST) assays using live cells on our proprietary instrument and consumable platform. To prepare for and manage clinical studies for our diagnostic assays, we are hiring a Senior Clinical Research Associate to join our Clinical Affairs team. In this role, you will support external studies, including site selection, site initiation visits and routine monitoring. Serving as the liaison between clinical sites and Pattern teams, you’ll have the opportunity to collaborate across the organization including with Assay Development, Hardware, Software, Quality, and Regulatory. This role is for you if you enjoy combining your passion for infectious disease or diagnostics with organizational and communication skills to support building new partnerships with clinical study sites.

Requirements

Self-prioritize work effectively, applying strong organizational skills
Demonstrate attention to detail and accuracy when delivering and following instructions and when reviewing and generating data and documents
Are teachable and love new challenges and learning new technology
Adapt quickly to changing priorities, timelines, and goals; are flexible with shifting strategies; and think nimbly to generate creative solutions
Love developing and creating organizational infrastructure
Have strong communication skills
Have a customer-centric mindset
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 Haves

Hands-on lab experience in microbiology and applied knowledge of bacteriology (a plus)
Experience working with clinical specimens and microorganisms (a plus)
Working knowledge of general workflows in a clinical microbiology laboratory, including Gram-stains, organism identification, conventional culture, and AST (a plus)
Knowledge and experience in performing and interpreting antibiotic susceptibility testing (AST) (could be in an industry, research, or clinical laboratory setting) (a plus)

Responsibilities

Set up and support sites for clinical trials and other external studies—including providing training, maintaining close communication, organizing study documents, and helping with study logistics
Optimize clinical study workflows and implementation
Ensure studies are conducted, monitored, and documented according to GCP and Pattern Bioscience SOPs
Assist in the build and validation of electronic data capture systems
Review/monitor data from active external studies, ensuring all errors are caught and queries appropriately resolved
Collaborate with Pattern’s R&D and/or Microbiology teams
Contribute to drafting SOPs, study manuals, and other clinical documents