Karius · 2 months ago
Clinical Development Scientist
Redwood City, CA (Hybrid) or Remote (USA)
Full-time
Hybrid
Mid, Senior Level
3+ years expKarius is a venture-backed life science startup transforming the observation of pathogens through microbial cell-free DNA. The Clinical Development Scientist will design and execute clinical studies, develop study protocols, and collaborate with cross-functional teams to generate clinical evidence for regulatory submissions.
BiotechnologyGeneticsHealth CareInformation TechnologyLife SciencePrecision Medicine
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
Qualification
Required
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
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
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
Company
Karius
Karius delivers genomic insights into infectious diseases, helping clinicians make critical, life-saving treatment decisions.
51-200 employees
H1B Sponsorship
Karius has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2021 (4)
Funding
Current Stage
Growth StageTotal Funding
$354MKey Investors
SoftBank Vision FundOxford Finance LLCDCVC
2024-05-02Series C· $100M
2020-02-24Series B· $165M
2018-11-30Debt Financing· $25M
Leadership Team
Alexander Ford
Chief Executive Officer
Tim Blauwkamp
Chief Scientific Officer, Co-founder
Recent News
General Catalyst
2026-01-06
2025-05-04
Company data provided by crunchbase