Teams at Oruka Therapeutics

Maintains electronic Trial Master Files throughout clinical studies, ensuring accurate, complete, timely, compliant, and inspection-ready documentation. Performs TMF quality control, reconciliation, health metric monitoring, issue resolution, vendor and CRO coordination, audit and inspection preparation, and process improvement. Supports TMF plans, SOPs, training, system adoption, and continuous compliance with ICH-GCP, regulatory requirements, and company procedures.

Supports Clinical Pharmacology and Nonclinical development programs by managing project timelines, deliverables, meetings, reviews, vendors, budgets, contracts, and operational tools. The role coordinates cross-functional activities, tracks risks and action items, facilitates document approvals, and improves project management processes. Candidates should have scientific or technical training, pharmaceutical or biotech experience, strong communication skills, and proficiency with project management tools.

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.