Director, Clinical Data Infrastructure

Summary

Join Karius, a life science startup, as their Director of Clinical Data Infrastructure. You will design and implement scalable, compliant data systems to support the Clinical Affairs team. Lead the development of infrastructure and SOPs for clinical data handling, ensuring regulatory alignment. Contribute to Karius' enterprise-wide data lake, integrating data from various sources. Collaborate with statisticians and clinical scientists to generate insights. This role offers the chance to make a life-changing impact on people through advancements in infectious disease diagnostics. The position is based in Redwood City, CA (hybrid) or remote (USA).

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)
• Proficiency 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
• Travel required up to 30% for onsite team meetings
• 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

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

Preferred Qualifications

• 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
• 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