Clinical Development Scientist position at KARIUS.| United States Of America

KARIUS Clinical Development Scientist

Experience: 5-years

Pattern: hybrid

Country:

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Bachelor's (B.Sc.)

Redwood City, ..........United States Of America

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. The ideal candidate will have a strong background in clinical research and molecular diagnostics with a proven ability to drive study design & implementation in a fast-paced, scientifically rigorous environment. This individual will collaborate closely with external stakeholders including key opinion leaders (KOLs) and Investigators. Provides support for clinical evidence discussions with regulatory agencies, notified bodies, and physician advisory boards. You will communicate across all levels of the organization and need to be able to develop a rapport with indirect or functional leaders to influence decision-making and facilitate change. You will be part of a cross-functional team that includes the medical, clinical, commercial, and product teams as we build future products to solve some of the toughest problems in infectious diseases. __ Why Should You Join Us? #Karius aims to conquer infectious diseases through innovations around genomic sequencing and machine learning. The company’s platform is already delivering unprecedented insights into the microbial landscape, providing clinicians with a comprehensive test capable of identifying more than a thousand pathogens directly from blood, and helping industry accelerate the development of therapeutic solutions. The Karius test we provide today is one of the most advanced solutions available to physicians who aim to deliver better care to many otherwise ineffectively treated patients. Our test is the result of some incredible work done by our scientists, statisticians, engineers, and physicians, all driven by the same mission. You, as part of the Karius team, will be able to see how directly your work has a life-changing impact on people, and at scale. Reports to: Sr. Vice President, Clinical Affairs Location: Redwood City, CA (Hybrid) or Remote (USA) __ Primary 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. __ What’s Fun About the Job? Karius is operating at the edge of what is now known to be possible in infectious disease diagnostics. With that, comes a wave of new and incredible challenges and opportunities. To deliver on that value, you will be tapping into some of the most advanced technologies, architecting and innovating where the current solutions simply don't suffice. You will get to see how much your work really matters. Travel: Travel up to 25%. __ Physical Requirements Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Position Requirements • 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. __ Personal Qualifications • 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.

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Clinical Development Scientist job opportunity at KARIUS.

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