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Artiva Biotherapeutics is a clinical-stage biotechnology company developing natural killer (NK) cell-based therapies for autoimmune diseases. The Associate Director, Biomarker Operations will report to the SVP of Research & Early Development and oversee all operational aspects of clinical and translational biomarker projects.
Key responsibilities include:
- Establishing and executing biomarker operations strategy across Artiva's clinical trials, defining best practices and standards
- Leading a team of biomarker operations professionals supporting current and planned clinical studies
- Managing day-to-day biomarker operations with external vendors, central labs, and CROs; ensuring deliverables and timelines are met
- Overseeing collection kit preparation, sample tracking, testing database builds, and documentation review
- Coordinating sample logistics, inventory management, shipping, and testing scheduling with central lab and third-party vendors
- Tracking biomarker assay performance, ensuring timely delivery of high-quality data, and supporting CRO audits
- Preparing site activation materials and training documentation in collaboration with Clinical Operations
- Managing central lab budgets, contract oversight, and vendor invoice tracking
- Coordinating with Finance, Procurement, and Legal on contract execution and budget management
- Facilitating communication between central lab, CROs, translational science team, and internal lab personnel
- Attending study team meetings as the Biomarker Operations representative
The ideal candidate has 6-10 years of biotechnology or pharmaceutical industry experience, with demonstrated expertise managing biomarker sample operations in clinical trials. A Bachelor's or Master's degree in biology, immunology, or related fields is required. Strong project management, communication, and interpersonal skills are essential, along with understanding of drug development and clinical trial processes.