Karius is a venture-backed life science startup focused on transforming the way infectious diseases are diagnosed. Combining Next-Generation Sequencing and proprietary data analysis, we can identify over 1,000 pathogens from a single blood sample with typical turnaround time in one business day. By unlocking the information present in microbial cell-free DNA, we're helping doctors quickly solve their most challenging cases, with a future vision of accelerating clinical trials, discovering new microbes, and reducing patient suffering worldwide.
We are looking for an outstanding Clinician to lead in the design and execution of our pivotal clinical trials. You will provide strategic leadership in developing the evidence necessary to achieve adoption, reimbursement and regulatory approval. You will also provide medical and scientific support to sites throughout study execution and support our publication strategy efforts.
You will provide medical leadership in cross-functional teams that include the commercial, clinical, operations, and product teams as we build future products to solve some of the toughest problems in infectious diseases.
•Provide clinical insights into future product development and enhancements
•Develop clinical development strategy with executive team
•Plan, design, and execute pivotal clinical validation, clinical utility, and health economic studies to facilitate adoption of the Karius Test in the market
•Provide medical and/or scientific expertise and leadership to project team during lifecycle of study
•Generate reports and data to aid in regulatory submissions as well as generate and/or review publications, posters, and scientific presentations
•Provide medical leadership in all grant requests for support of Investigator Initiated Studies
•Doctoral-level degree in the Life Sciences (MD or DO)
•Post-graduate training or prior industry experience in infectious diseases, highly preferred
•Minimum 5 years of experience in a clinical setting and/or industry, preferred
•Excellent analytical skills and solid experience in translating medical/scientific information into medical affairs and clinical development strategies
•Expertise in scientific and clinical data review and interpretation
•Outstanding communication skills including public speaking, written communication, and interpersonal skills
•Experience writing clinical study reports, poster presentations, and manuscripts for publication in a scientific journal preferred
•Project leadership and management skills
•Ability to travel 10-20%
•Role model for Karius values