Director, Clinical Program Management
Bristol-Myers SquibbFull Time
Expert & Leadership (9+ years)
The Director of Clinical Data Management & Engineering should have experience in managing and operationalizing clinical data for analysis, designing and implementing compliant, scalable processes for data access, ingestion, and transformation, and working within enterprise infrastructure and governance frameworks. Experience with regulatory alignment, operational excellence, data analysis and visualization, and supporting data analysis and visualization, and collaborating with statisticians and clinical scientists is expected. Experience or interest in supporting data analysis and visualization, and collaborating with statisticians and clinical scientists to generate insights from study and operational data is also desired. Depending on experience, operational oversight of Biostatistics team structure and resourcing may be required.
The Director will oversee, manage, and optimize all aspects of the data management process for clinical trials and collaborations. They will develop and implement data management strategies and procedures to ensure accuracy, completeness, and timeliness of data. Responsibilities include collaborating with cross-functional teams to define and implement data standards and processes, conducting regular quality checks and audits to ensure data integrity and compliance with regulatory requirements, and identifying and analyzing data trends to improve data management processes and drive efficiency. The role involves managing and prioritizing multiple projects, ensuring timely completion and delivery of high-quality data, and designing and operationalizing clinical data workflows to support study operations, regulatory readiness, and long-term reusability of data. Collaboration with Engineering and Information Security & Compliance teams to define and enforce SOPs for clinical data ingestion, transformation, secure storage, access, and handoff, ensuring GCP and HIPAA compliance, is crucial. The Director will manage data pipelines and integrations from EDC, LIMS, ePRO, and lab systems, ensuring interoperability with downstream analysis environments.
Non-invasive diagnostic tests for infections
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.