Karius is hiring a
Senior Director, Clinical Development

Summary

The Senior Director of Clinical Development at Karius is responsible for providing leadership in the design and execution of clinical studies to support new product features and advance clinical evidence for Karius products. The role requires a doctoral-level degree in Medicine or an equivalent combination of education and experience, with at least 8 years of professional experience in a clinical setting or diagnostic industry focused on infectious disease, including at least 3 years in a leadership role.

Requirements

• Doctoral-level degree in Medicine (MD or DO); an equivalent combination of education in Life Sciences (Ph.D.) and experience may be considered
• 8+ years professional experience in a clinical setting or diagnostic industry focused on infectious disease, with at least 3 years in a leadership role

Responsibilities

• Hands-on design of clinical trials, including selecting appropriate study designs, endpoints, and patient populations to facilitate adoption, regulatory approval and/or reimbursement of the Karius Test for infectious disease indications
• Provide medical and/or scientific expertise to the project team during the lifecycle of study
• Author major written deliverables including, protocols, clinical study reports, regulatory submissions, original articles, abstracts, posters and presentation materials
• Architect clinical evidence development strategy for Karius Test intended uses with executive team and aligned with company product strategy
• Collaborate with the Clinical Operations team on execution and delivery of multiple concurrent clinical studies
• Collaborate with Biostatistics to develop and execute study statistical analysis plans
• Provide clinical guidance into future product development and enhancements
• Provide medical leadership on grant requests for support of Investigator Initiated Studies
• Guide and mentor junior team members and foster their professional growth

Preferred Qualifications

• Proven ability to develop a clear roadmap for the clinical program, making critical decisions about trial design, endpoints and patient populations
• Experience designing clinical studies to support both FDA approvals and CMS reimbursement. Specific experience designing trials to support breakthrough device submissions is a plus
• Extensive experience in designing, planning, and executing clinical trials is essential. This involves knowledge of trial methodologies to support clinical validity and utility evidence generation for Laboratory Developed Tests and In Vitro Diagnostics. Cell-free DNA-based applications or similar applications is preferred
• Successful design, execution, and publication of at least one multi-center prospective clinical study in infectious disease
• Expertise in scientific and clinical data review and interpretation
• Track-record of producing outstanding clinical study protocols, clinical study reports, publications and poster presentations
• Project leadership and management skills
• Strong commitment to ethics and compliance

Benefits

• Remote or Hybrid work location
• Travel required up to 10%
• Competitive salary range: $240,000 - $310,000 a year