Clinical Development Scientist

Company: Karius
Location: Redwood City
Posted on: November 2, 2024

Job Description:

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 AffairsLocation: Redwood City, CA or HybridPrimary 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 required 10% to 20%Physical RequirementsSubject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels.Position 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.Personal QualificationsStrong 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, good clinical and data management practices. Demonstrated ability to thrive in a cross-functional environment focused on company-level goals.DisclaimerThe above job description is intended to describe the general nature and level of work being performed by individuals assigned to this position. It is not intended to be an exhaustive list of all duties, responsibilities, and skills required. Responsibilities and duties may change or be adjusted to meet the needs of the company, and additional duties may be assigned as necessary. The job description is subject to change at any time at the discretion of Karius.At Karius, we value a diverse and inclusive workplace and provide equal employment opportunities for all applicants and employees, and are committed to honor and invest in the full diversity of people, in our hiring, recruiting, and development of employees across the Company. All qualified applicants for employment are encouraged to apply and will be considered without regard to an individual's race, color, sex, gender identity, and gender expression (including transgender individuals who are transitioning, have transitioned, or are perceived to be transitioning to the gender with which they identify), religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws. If you are unable to submit your application due to a disability, please contact us at recruiting@kariusdx.com and we will accommodate qualified individuals with disabilities.
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Keywords: Karius, Santa Rosa , Clinical Development Scientist, Healthcare , Redwood City, California