Remote Senior Clinical Development Scientist

Summary

Join Karius, a venture-backed life science startup, as a Senior Clinical Development Scientist to play a pivotal role in steering the clinical strategy that supports the company’s diagnostic products. This role involves hands-on leadership and design of clinical trials, providing medical and/or scientific expertise, authoring written deliverables, and collaborating with cross-functional teams.

Requirements

• A Master's degree (in Public Health); a Ph.D. or MD is desired
• 5+ years professional experience in research & or diagnostic industry
• Proven ability to lead the design & execution of clinical studies
• Experience designing clinical studies to support both FDA approvals and CMS reimbursement
• 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
• 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

Responsibilities

• Hands-on leadership and design of clinical trials
• Provide medical and/or scientific expertise to the project team during the lifecycle of the 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 leadership on grant requests for support of investigator-initiated Initiated Studies
• Guide and mentor junior team members and foster their professional growth. Provide leadership by example and support the development of a strong clinical affairs team

Benefits

• Health insurance
• Retirement benefits
• Paid time off
• Remote work, flexible hours