Director, Clinical Development | Karius

Director, Clinical Development

Karius is a venture-backed life science startup that is transforming the way pathogens and other microbes are observed throughout the body.  By unlocking the information present in microbial cell-free DNA, we're helping doctors quickly solve their most challenging cases, providing industry partners with access to 1000’s of biomarkers to accelerate clinical trials, discovering new microbes, and reducing patient suffering worldwide.
 
Position Summary:
Karius is seeking a Director to be part of the clinical development team that oversees the design, planning, execution and analysis of clinical programs across our product portfolio. You will provide thought leadership in developing the evidence necessary to evaluate the utility of our approach, drive adoption, gain reimbursement and regulatory approval.  You will participate in cross-functional teams that include commercial, clinical, operations, and product as we build future products to solve some of the toughest problems in infectious diseases. The Director, Clinical Development will also provide medical/scientific support to sites throughout study execution, support our publication strategy efforts, and present study results to a variety of stakeholders. 
 
Reports to: CSO
 
Location: Redwood City, CA
 
Responsibilities Include:
 
·      Design and publish clinical validation, clinical utility, and health economic studies that uncover and demonstrate the most valuable applications of the Karius Test in the infectious disease market
·      Provide clinical and scientific guidance into future product development and enhancements
·      Provide medical and/or scientific expertise and leadership to project team during lifecycle of study
·      Generate and/or review publications, posters, and scientific presentations
·      Generate reports and data to aid in regulatory submissions
·      Provide medical/scientific leadership in requests for grant support of Investigator Initiated Studies
·      Build and maintain collaborative relationships with investigators, thought leaders and institutions
 
Travel:
·      10% - 20%
 
Physical Requirements:  
·      Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. 
 
Position Requirements:
 
·      Advanced degree in the Life Sciences (PhD, MD or DO)
·      Minimum 8 years professional experience in a clinical setting and/or industry related to infectious disease
·     Participate in the successful design, execution, and publication of at least one multi-center prospective clinical utility or health economics focused study in infectious disease
·      Expertise in scientific and clinical data review and interpretation
·      Outstanding communication skills including public speaking and written communication
·      Demonstrated ability to thrive in cross-functional environment focused on company-level goals
·      Track-record of producing outstanding publications, clinical study reports, and poster presentations
·      Project leadership and management skills
 
 

Full-time
Redwood City, CA