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Clinical Development Scientist
KariusRedwood City, United StatesRemotefull_timeVerifiedPosted 29 Oct 2024
About the role
About KariusKarius 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.
Position SummaryWe 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 operations, 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*This position is not open to agency support at this time. Agencies, please contact recruiting@kariusdx.com and not the hiring manager for inquiries.
Location: Redwood City, CA (Hybrid) or Remotely (US only)
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
Position SummaryWe 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 operations, 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*This position is not open to agency support at this time. Agencies, please contact recruiting@kariusdx.com and not the hiring manager for inquiries.
Location: Redwood City, CA (Hybrid) or Remotely (US only)
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
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