Clinical Development Scientist

Summary

Join Karius as a Clinical Development Scientist to design and execute clinical studies, collaborate with cross-functional teams, and develop study protocols. The ideal candidate will have a strong background in clinical research and molecular diagnostics.

Requirements

• A Master's degree (in Public Health); a Ph.D. or MD is desired
• 3 to 5 years of scientific/research background with experience in clinical research (preferably molecular diagnostics) conduct including methodology and statistics
• Experience in scientific and clinical data review and interpretation
• Project leadership and management skills

Responsibilities

• Support the development of clinical protocols, amendments, case report forms, and data analysis interpretation
• Conduct secondary research, including literature reviews to support study design
• Assist in the preparation of study reports and other regulatory and/or reimbursement documents
• Collaborate with the trial operations team on execution, and delivery of multiple clinical studies
• Collaborate with biostatistics to develop and execute study statistical analysis plans
• Ensure compliance with relevant regulations, guidelines, and SOPs
• Help manage study data and maintain documentation
• Participate in major written deliverables (e.g. protocols, clinical study reports, regulatory submissions, original articles, abstracts, posters and presentation materials) in collaboration with Medical and Clinical Affairs team members
• Support the development of SOPs, policies and work instructions as part of continuous improvement initiatives
• Actively participate in clinical study oversight, including monitoring study progress, ensuring compliance with regulatory requirements, and addressing any clinical issues that arise
• Lead data interpretation sessions and assist in preparing clinical results for publication in peer-reviewed journals or conference presentations
• Support the creation of regulatory documentation and submissions to ensure compliance with FDA and other regulatory bodies