[Hiring] Clinical Development Scientist @Kariusdx

Role Description

We are seeking a passionate Clinical Development Scientist who will be responsible for the design and execution of our clinical studies. By working closely with cross-functional teams, you will develop study protocols, analyze data, and generate clinical evidence to support regulatory submissions.

• 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.

Qualifications

• A minimum of a Master's of Public Health, Ph.D., or MD.
• A minimum of 3-5 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.

Requirements

• Strong medical writing experience, effective verbal communication, and presentation skills in technical/clinical applications, and experience in the conduct of literature searches pertinent to clinical/medical research.
• You possess knowledge of clinical research, device development processes, regulatory requirements, and good clinical and data management practices.
• Demonstrated ability to thrive in a cross-functional environment focused on company-level goals.

Benefits

• Travel up to 25%.

Company Description

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 the microbial landscape to accelerate biomarker discovery and clinical trials, discover novel microbes, to ultimately reduce patient suffering worldwide.