Clinical Development Scientist at Karius

Redwood City, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, BiotechnologyIndustries

Requirements

Strong background in clinical research and molecular diagnostics
Proven ability to drive study design and implementation in a fast-paced, scientifically rigorous environment
Ability to collaborate closely with external stakeholders, including key opinion leaders (KOLs) and Investigators
Capability to provide support for clinical evidence discussions with regulatory agencies, notified bodies, and physician advisory boards
Strong communication skills across all levels of the organization, with ability to develop rapport with indirect or functional leaders to influence decision-making and facilitate change
Passion for clinical development and working in cross-functional teams (medical, clinical, commercial, product)

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

Skills

Clinical Research

Molecular Diagnostics

Study Design

Protocol Development

Data Analysis

Regulatory Submissions

Genomic Sequencing

Machine Learning

Karius

Non-invasive diagnostic tests for infections

About Karius

Karius focuses on medical diagnostics for infectious diseases, offering the Karius Test, which detects over 1,000 pathogens from a single blood sample. This non-invasive test is quick and helps clinicians treat hospitalized patients by reducing the need for multiple invasive tests that can delay treatment. The Karius Test utilizes advanced genomics and artificial intelligence to identify microbial cell-free DNA (mcfDNA) in the bloodstream, providing insights into the pathogens responsible for infections. Karius sells these diagnostic tests to healthcare providers, aiming to offer a faster and less invasive alternative to traditional methods, ultimately saving lives and reducing healthcare costs. The company employs proprietary machine learning algorithms to analyze genomic data in real time, continuously updating its reference genome databases to enhance its diagnostic capabilities.

Redwood City, CaliforniaHeadquarters

2014Year Founded

$311.3MTotal Funding

SERIES_CCompany Stage

Biotechnology, HealthcareIndustries

51-200Employees

Benefits

Remote Work Options

Hybrid Work Options

Risks

Competition from AlphaFold 3 could overlap with Karius's genomic insights.

Rapid AI advancements by competitors may outpace Karius's technology.

Reliance on continuous funding rounds indicates potential financial instability.

Differentiation

Karius Test detects over 1,000 pathogens from a single blood sample.

The test uses advanced genomics and AI for rapid, non-invasive diagnostics.

Karius's proprietary algorithms analyze genomic data in real time.

Upsides

Karius secured $100M to expand its test beyond 400 U.S. hospitals.

FDA Breakthrough Device Designation boosts credibility and market potential.

Growing demand for non-invasive diagnostics aligns with Karius's offerings.

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