Principal, Scientific & Medical Affairs
<p><span data-contrast="auto">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.</span><span data-ccp-props="{" 201341983":1,"335559740":340}"=""> </span></p> <p><span data-contrast="auto">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. </span><span data-ccp-props="{" 201341983":1,"335559740":340}"=""> </span></p> <p><strong><span data-contrast="auto"><span data-ccp-parastyle="heading 1">How </span><span data-ccp-parastyle="heading 1">Y</span><span data-ccp-parastyle="heading 1">ou </span><span data-ccp-parastyle="heading 1">W</span><span data-ccp-parastyle="heading 1">ill </span><span data-ccp-parastyle="heading 1">C</span><span data-ccp-parastyle="heading 1">ontribute</span></span></strong><span data-ccp-props="{" 134245418":true,"134245529":true,"201341983":1,"335559738":240,"335559740":340}"=""> </span></p> <ul> <li><span data-contrast="auto">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</span><span data-ccp-props="{" 201341983":1,"335559740":340}"=""> </span></li> <li><span data-contrast="auto">Optimize clinical study workflows and implementation</span><span data-ccp-props="{" 201341983":1,"335559740":340}"=""> </span></li> <li><span data-contrast="auto">Ensure studies are conducted, monitored, and documented according to GCP and Pattern Bioscience SOPs</span><span data-ccp-props="{" 201341983":1,"335559740":340}"=""> </span></li> <li><span data-contrast="auto">Assist in the build and validation of electronic data capture systems</span><span data-ccp-props="{" 201341983":1,"335559740":340}"=""> </span></li> <li><span data-contrast="auto">Review/monitor data from active external studies, ensuring all errors are caught and queries appropriately resolved</span><span data-ccp-props="{" 201341983":1,"335559740":340}"=""> </span></li> <li><span data-contrast="auto">Collaborate with Pattern’s R&D and/or Microbiology teams </span><span data-ccp-props="{" 201341983":1,"335559740":340}"=""> </span></li> <li><span data-contrast="auto">Contribute to drafting SOPs, study manuals, and other clinical documents</span><span data-ccp-props="{" 201341983":1,"335559740":340}"=""> </span></li> </ul> <h4><span data-contrast="auto"><span data-ccp-parastyle="heading 1">We'd</span><span data-ccp-parastyle="heading 1"> Love to Hear </span><span data-ccp-parastyle="heading 1">f</span><span data-ccp-parastyle="heading 1">rom You If You</span></span></h4> <ul> <li><span data-contrast="auto">Self-prioritize work effectively, applying strong organizational skills</span><span data-ccp-props="{" 201341983":1,"335559740":340}"=""> </span></li> <li><span data-contrast="auto">Demonstrate attention to detail and accuracy when delivering and following instructions and when reviewing and generating data and documents</span><span data-ccp-props="{" 201341983":1,"335559740":340}"=""> </span></li> <li><span data-contrast="auto">Are teachable and love new challenges and learning new technology</span><span data-ccp-props="{" 201341983":1,"335559740":340}"=""> </span></li> <li><span data-contrast="auto">Adapt quickly to changing priorities, timelines, and goals; are flexible with shifting strategies; and think nimbly to generate creative solutions</span><span data-ccp-props="{" 201341983":1,"335559740":340}"=""> </span></li> <li><span data-contrast="auto">Love developing and creating organizational infrastructure</span><span data-ccp-props="{" 201341983":1,"335559740":340}"=""> </span></li> <li><span data-contrast="auto">Have strong communication skills</span><span data-ccp-props="{" 201341983":1,"335559740":340}"=""> </span></li> <li><span data-contrast="auto">Have a customer-centric mindset </span><span data-ccp-props="{" 201341983":1,"335559740":340}"=""> </span></li> </ul> <p> </p> <h4><strong><span data-contrast="auto"><span data-ccp-parastyle="heading 1">Goals</span></span></strong></h4> <p><span data-contrast="auto">90 days:</span><span data-ccp-props="{" 201341983":1,"335559740":340}"=""> </span></p> <ul> <li><span data-contrast="auto">Become familiar with Pattern technology and assay/instrument workflows</span><span data-ccp-props="{" 201341983":1,"335559740":340}"=""> </span></li> <li><span data-contrast="auto">Perform site/data monitoring for clinical studies </span><span data-ccp-props="{" 201341983":1,"335559740":340}"=""> </span></li> <li><span data-contrast="auto">Organize and maintain study documents and data files </span><span data-ccp-props="{" 201341983":1,"335559740":340}"=""> </span></li> <li><span data-contrast="auto">Contribute to qualification of potential clinical study sites for upcoming studies </span><span data-ccp-props="{" 201341983":1,"335559740":340}"=""> </span></li> <li><span data-contrast="auto">Help coordinate clinical specimen shipments from clinical partners to Pattern </span><span data-ccp-props="{" 201341983":1,"335559740":340}"=""> </span></li> <li><span data-contrast="auto">Participate in Clinical Study preparedness activities</span><span data-ccp-props="{" 201341983":1,"335559740":340}"=""> </span></li> <li><span data-contrast="auto">Participate in study site start up activities</span><span data-ccp-props="{" 201341983":1,"335559740":340}"=""> </span></li> </ul> <p><span data-contrast="auto">6 months: </span><span data-ccp-props="{" 201341983":1,"335559740":340}"=""> </span></p> <ul> <li><span data-contrast="auto">Support Pneumonia ID/AST clinical study initiation at external sites</span><span data-ccp-props="{" 201341983":1,"335559740":340}"=""> </span></li> <li><span data-contrast="auto">Organize Pneumonia ID/AST clinical study master files</span><span data-ccp-props="{" 201341983":1,"335559740":340}"=""> </span></li> <li><span data-contrast="auto">Support set up and execution of analytical validation studies (e.g., reproducibility study) </span><span data-ccp-props="{" 201341983":1,"335559740":340}"=""> </span></li> <li><span data-contrast="auto">Build strong relationships/credibility with other internal teams as well as external clinical sites/vendors</span><span data-ccp-props="{" 201341983":1,"335559740":340}"=""> </span></li> </ul> <p> </p> <h4><span data-contrast="auto"><span data-ccp-parastyle="heading 1">Desired </span><span data-ccp-parastyle="heading 1">Education and Experience</span></span></h4> <ul> <li><span data-contrast="auto">B.S. in biological sciences, medical laboratory science, or related field</span><span data-ccp-props="{" 201341983":1,"335559740":340}"=""> </span></li> <li><span data-contrast="auto">3-5 Years' experience in actively </span><strong><span data-contrast="auto">managing multi-site diagnostic device clinical trials</span></strong><span data-contrast="auto">, managing clinical study documentation/clinical study master files</span><span data-ccp-props="{" 201341983":1,"335559740":340}"=""> </span></li> <li><span data-contrast="auto">Knowledge of GCP and FDA regulations related to conducting IVD/device clinical trials</span><span data-ccp-props="{" 201341983":1,"335559740":340}"=""> </span></li> <li><span data-contrast="auto">Hands-on lab experience in </span><strong><span data-contrast="auto">microbiology and applied knowledge of bacteriology</span></strong><span data-ccp-props="{" 201341983":1,"335559740":340}"=""> (a plus)</span></li> <li><span data-contrast="auto">Experience working with clinical specimens and microorganisms</span><span data-ccp-props="{" 201341983":1,"335559740":340}"=""> (a plus)</span></li> <li><span data-contrast="auto">Working knowledge of general workflows in a clinical microbiology laboratory, including Gram-stains, organism identification, conventional culture, and AST</span><span data-ccp-props="{" 201341983":1,"335559740":340}"=""> (a plus)</span></li> <li data-leveltext="" data-font="Symbol" data-listid="23" data-list-defn-props="{" 335552541":1,"335559685":720,"335559991":360,"469769226":"symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridmultilevel"}"="" data-aria-posinset="21" data-aria-level="1"><span data-contrast="auto">Knowledge and experience in performing and interpreting antibiotic susceptibility testing (AST) (could be in an industry, research, or clinical laboratory setting)</span><span data-ccp-props="{" 201341983":1,"335559740":340}"=""> (a plus)</span></li> </ul> <h4><span data-ccp-props="{" 201341983":0,"335557856":16777215,"335559740":240}"=""> </span><span data-contrast="auto"><span data-ccp-parastyle="heading 1">Details</span></span></h4> <p><strong><span data-contrast="auto"><span data-ccp-charstyle="normaltextrun" data-ccp-charstyle-defn="{" objectid":"ac0262f4-8a9e-5820-b908-2d943c5f7113|1","classid":1073872969,"properties":[201342446,"1",201342447,"5",201342448,"1",201342449,"1",469777841,"calibri",469777842,"",469777843,"calibri",469777844,"calibri",201341986,"1",469769226,"calibri",268442635,"24",469775450,"normaltextrun",201340122,"1",134233614,"true",469778129,"normaltextrun",335572020,"1",469778324,"default="" paragraph="" font"]}"="">Travel Expectations: </span></span></strong><span data-contrast="auto"><span data-ccp-charstyle="normaltextrun" data-ccp-charstyle-defn="{" objectid":"ac0262f4-8a9e-5820-b908-2d943c5f7113|1","classid":1073872969,"properties":[201342446,"1",201342447,"5",201342448,"1",201342449,"1",469777841,"calibri",469777842,"",469777843,"calibri",469777844,"calibri",201341986,"1",469769226,"calibri",268442635,"24",469775450,"normaltextrun",201340122,"1",134233614,"true",469778129,"normaltextrun",335572020,"1",469778324,"default="" paragraph="" font"]}"="">A</span></span><span data-contrast="auto"><span data-ccp-charstyle="normaltextrun">verage </span><span data-ccp-charstyle="normaltextrun">of </span><span data-ccp-charstyle="normaltextrun">50% travel </span><span data-ccp-charstyle="normaltextrun">required</span><span data-ccp-charstyle="eop" data-ccp-charstyle-defn="{" objectid":"920dbcde-2834-5e15-a5fa-062170b236ba|1","classid":1073872969,"properties":[201342446,"1",201342447,"5",201342448,"1",201342449,"1",469777841,"calibri",469777842,"",469777843,"calibri",469777844,"calibri",201341986,"1",469769226,"calibri",268442635,"24",469775450,"eop",201340122,"1",134233614,"true",469778129,"eop",335572020,"1",469778324,"default="" paragraph="" font"]}"=""> </span><span data-ccp-charstyle="eop">with up to 75% travel during </span><span data-ccp-charstyle="eop">peak</span><span data-ccp-charstyle="eop"> times</span></span><span data-ccp-props="{" 134233117":false,"134233118":false,"201341983":0,"335559738":0,"335559739":0,"335559740":240}"=""> </span></p> <p><strong><span data-contrast="auto"><span data-ccp-charstyle="normaltextrun">Type of Position:</span></span></strong><span data-contrast="auto"><span data-ccp-charstyle="normaltextrun"> Exempt, Full-time</span></span></p> <p><span data-contrast="auto">Join us! We're excited for what you can bring to our team. Here are a few things we provide to make sure you have a great experience. Learn more about our team by visiting our </span><a href="http://www.pattern.bio/"><span data-contrast="auto"><span data-ccp-charstyle="Hyperlink">website.</span></span></a><span data-ccp-props="{" 201341983":1,"335559740":340}"=""> </span></p> <h4><span data-contrast="auto">Benefits</span></h4> <ul> <li><span data-ccp-props="{" 201341983":1,"335559740":340}"="">H</span><span data-contrast="auto">ealth insurance</span><span data-ccp-props="{" 201341983":1,"335559740":340}"=""> </span></li> <li><span data-contrast="auto">401k Matching</span><span data-ccp-props="{" 201341983":1,"335559740":340}"=""> </span></li> <li><span data-contrast="auto">Paid Time Off</span><span data-ccp-props="{" 201341983":1,"335559740":340}"=""> </span></li> <li><span data-contrast="auto">The opportunity to make a global impact</span></li> </ul> <p><span data-contrast="auto">To fulfill our mission and build world-changing technology, we’ve put together a diverse, multi-disciplinary top-notch team, a culture of innovation, learning, adaptability, and excellence and environment where people love coming to work.</span><span data-ccp-props="{" 201341983":1,"335559740":340}"=""> </span></p> <p><span data-contrast="auto"> </span><span data-contrast="auto">We value diversity on our teams. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity or expression, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law. </span><span data-ccp-props="{" 201341983":1,"335559740":340}"=""> </span></p>