Senior Manager, Clinical Supply Chain – Biologics

Waltham, Massachusetts, United States

About Us:

Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases.

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As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger. Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture.

Job Title: Senior Manager, Clinical Supply Chain – Biologics

Location:
Hybrid – Waltham, MA. Candidates will be required to be in-office 3 days/week.

Role Overview:

We are seeking an experienced and highly motivated Senior Manager, Clinical Supply Chain to lead clinical supply activities supporting early- through late-stage global clinical trials. This individual will be responsible for the planning and execution of clinical supply strategies, including forecasting, labeling, packaging, distribution, inventory management, Interactive Response Technology (IRT) implementation and maintenance, expiry management, and supply reconciliation.

The ideal candidate thrives in a fast-paced, collaborative environment and has demonstrated experience building strong relationships across Clinical Operations, CMC, Program Management, Regulatory Affairs, Quality, and external partners. This individual will work closely with the broader Clinical Supply Chain team to establish scalable processes and best practices while supporting multiple clinical trials across the United States, Canada, and Europe.

The successful candidate will be a proactive and highly effective communicator who anticipates supply risks, develops practical solutions, and delivers results efficiently. Experience supporting global biologics programs involving vials, pre-filled syringes, temperature-controlled products, and active comparators is strongly preferred.

Key Responsibilities:

• Develop and execute clinical supply strategies for multiple early- and late-stage clinical programs, including Phase 1, Phase 2, and global Phase 3 studies.
• Lead clinical supply chain activities, including demand forecasting, labeling, packaging, distribution, inventory management, IRT implementation and maintenance, expiry management, returns, reconciliation, and destruction.
• Develop and maintain comprehensive supply plans aligned with clinical enrollment projections, dosing requirements, protocol assumptions, regulatory timelines, and study milestones.
• Author, review, and/or approve clinical label text, packaging specifications, packaging batch records, distribution documentation, pharmacy manuals, and clinical supply sections of study-related documents.
• Provide clinical supply subject‑matter expertise for label development, packaging design, distribution strategies, depot networks, kit configurations, and randomization and packaging requirements in accordance with applicable regulations and Good Manufacturing Practices.
• Lead the selection, onboarding, and operational oversight of contract packaging organizations, clinical depots, couriers, IRT vendors, and other external supply partners.
• Support site initiation…