Director, Clinical Data Infrastructure

About Karius

Karius 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 1000’s of biomarkers to accelerate clinical trials, discovering new microbes, and reducing patient suffering worldwide.

Position Summary

Karius is seeking a Director of Clinical Data Infrastructure with a primary focus on supporting the Clinical Affairs team in designing and implementing scalable, compliant, and analytics-ready data systems. This individual will lead the development of infrastructure and SOPs for clinical data handling, secure storage, and access, ensuring regulatory alignment and operational excellence across our clinical research programs. In addition to clinical responsibilities, the role will contribute to Karius' enterprise-wide data lake, helping integrate data from commercial, medical, and R&D sources into a unified platform. The ideal candidate will also bring experience or interest in supporting data analysis and visualization, collaborating with statisticians and clinical scientists to generate insights from study and operational data.

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

• Architect and maintain the clinical data infrastructure to support study operations, regulatory readiness, and long-term reusability of data.

• Develop and enforce SOPs for clinical data ingestion, transformation, secure storage, access, and handoff, ensuring GCP and HIPAA compliance.

• Manage data pipelines and integrations from EDC, LIMS, ePRO, and lab systems; ensure interoperability with downstream analysis environments (e.g., R, SAS).

• Partner with Clinical Development, Computational Biology and Bioinformatics to ensure data is audit-ready and analysis-ready.

• Act as a core stakeholder in the cross-functional data lake program, supporting ingestion and structuring of commercial, operational, and real-world data as needed.

• Support ad hoc data analyses and dashboard development for clinical program insights and cross-functional metrics tracking.

• Document and catalog metadata, enabling structured data access for internal and external partners.

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 up to 30% for onsite team meetings. 

Physical Requirements

• Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office, lab or clinical environment.

Position Requirements

• Minimum Bachelor’s degree in a relevant field such as clinical informatics, data management, science, bioengineering, computer science, or life sciences and 8-10 years of experience (Master’s or PhD preferred. Masters requires 6 years of experience; PhD requires 4  years of experience.) 

• 8-10 years of experience in clinical data management, clinical informatics, data engineering, or related roles in biotech, diagnostics, or healthcare.

• Proven ability to design and implement clinical data infrastructure, including pipeline development, metadata management, and quality control processes.

• Demonstrated experience with clinical systems and data types, including EDC, LIMS, ePRO, and associated regulatory frameworks (GCP, HIPAA, 21 CFR Part 11).

P• roficiency in SQL and Python, with experience developing or managing ETL workflows using tools like Airflow, dbt, or equivalent.

• Hands-on experience working in cloud environments (AWS, GCP, or Azure) for data engineering and storage solutions.

• Familiarity with data governance, access control models, and SOP development in regulated settings.

• Strong written and verbal communication skills, with ability to work across clinical, regulatory, and technical teams.

• Experience supporting or conducting clinical data analysis, including exploratory statistics or data visualization using tools like R, SAS, Tableau, or Python preferred.

• Exposure to commercial or real-world data sources, such as CRM (e.g., Salesforce), diagnostic pipeline data, or customer reporting systems.

• Knowledge of CDISC standards (SDTM, ADaM) and experience preparing datasets for regulatory submissions.

• Experience in a fast-paced, cross-functional environment, preferably in a startup or high growth-stage biotech company.

• Familiarity with DevOps or DataOps principles in the context of clinical or commercial data systems. 

Personal Qualifications

• High level of professionalism, integrity, and commitment to achieving results.

• Ability to thrive in a dynamic and rapidly evolving environment.

• Strong organizational skills and attention to detail.

• Passion for contributing to the company’s success and supporting its mission to advance diagnostic technologies.

Disclaimer

The 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.

Equal Opportunity Employer 

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 [email protected] and we will accommodate qualified individuals with disabilities.