Teams at Oruka Therapeutics

Support CMC program execution by coordinating late-stage manufacturing, process development, analytical, quality, and regulatory readiness activities. Manage CMC documentation workflows, trackers, meeting materials, risk and issue logs, and CDMO communications. Maintain timelines, track deliverables, escalate issues, and contribute to continuous improvement of project management tools and processes.

Manage clinical trial biospecimen operations across the sample lifecycle: coordinate collection, shipment, receipt, processing, storage, transfers, and chain-of-custody; reconcile sample inventories and data across systems; liaise with sites, central and specialty labs, CROs and vendors; support audits, SOPs, process improvements, and study reporting to ensure sample integrity and regulatory compliance.

The Director of Biostatistics will lead statistical strategy for clinical development programs, design studies, and provide statistical input for regulatory submissions while collaborating across teams.