Senior Manager, Clinical Supply Chain – Biologics

The role

This person will lead clinical supply activities for early- through late-stage global clinical trials. They will plan and execute strategies including forecasting, labeling, packaging, distribution, and inventory management.

What you will do

• Develop and execute clinical supply strategies for multiple early- and late-stage clinical programs.
• Lead clinical supply chain activities including forecasting, labeling, packaging, distribution, and inventory management.
• Develop and maintain supply plans aligned with clinical enrollment, dosing, and regulatory timelines.
• Author, review, and approve clinical label text, packaging specifications, and distribution documentation.
• Provide subject-matter expertise for label development, packaging design, and distribution strategies.
• Lead selection and operational oversight of contract packaging organizations, depots, couriers, and IRT vendors.
• Support site initiation visits and ongoing clinical trial activities.
• Identify and manage risks related to enrollment, protocol amendments, and supply availability.
• Support clinical supply and logistics planning for global regulatory submissions and inspections.
• Partner with Quality to facilitate review and execution of SOPs, batch records, and deviations.

Required qualifications

• Bachelor’s or Master’s in a scientific discipline
• 6+ years of relevant experience in clinical supply chain and logistics
• Experience planning and executing clinical supply strategies for complex, global clinical studies, including Phase 3 studies involving active or licensed comparators
• Hands-on experience managing forecasting, labeling, packaging, distribution, inventory management, IRT implementation, expiry management, reconciliation, returns, and destruction
• Experience supporting temperature-controlled biologic products, including cold-chain storage and distribution
• Experience supporting clinical supplies presented in vials and/or pre-filled syringes
• Experience managing import and export activities for clinical studies in the United States, Canada, and Europe
• Strong operational and project-management skills
• Experience working with IRT systems and clinical supply forecasting or inventory-management tools
• Ability to identify supply risks, evaluate alternatives, and communicate recommendations

Nice to have

• Experience supporting global biologics programs involving vials, pre-filled syringes, temperature-controlled products, and active comparators

Benefits

• Competitive salary and benefits package
• Vibrant startup culture
• Supportive and inclusive team environment
• Opportunities for professional growth and development

About the company

Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. The company is advancing a proprietary portfolio of potentially best-in-class antibodies.