Senior Clinical Supply Chain Lead, Biologics

Oruka Therapeutics Inc; Boston (MA); Ibrido; USD 161.000 - 187.000; Tempo pieno

Vantaggi offerti da questo lavoro

Equity

Bonus opportunity

Descrizione del lavoro

Oruka Therapeutics seeks a Senior Manager, Clinical Supply Chain – Biologics to lead global clinical supply activities from planning through execution. The role supports early- to late-stage trials across the US, Canada, and Europe within a fast-paced, cross-functional team.

The hybrid in-office/remote position is based in Waltham, MA, with a strong emphasis on collaboration with Regulatory, Quality, and Clinical Operations to ensure timely, compliant supply and continuous process improvements.

Competenze

• Experience leading clinical supply chain activities for global trials.
• Strong collaboration with Regulatory, QA, and Clinical Operations.

Mansioni

• Develop and execute clinical supply strategies for multiple early- and late-stage programs worldwide.
• Lead forecasting, labeling, packaging, distribution, inventory mgmt, IRT and expiry management.
• Create supply plans aligned with enrollment projections, dosing requirements, and regulatory timelines.
• Prepare and approve label text, packaging specs, batch records, distribution docs, and study materials.
• Provide SME input for label development, packaging design, and depot networks.
• Oversee selection and oversight of contract packagers, depots, couriers, and IRT vendors.
• Support site initiation visits and ongoing trial activities ensuring timely supplies and COA data.
• Identify and manage risks related to enrollment changes, timelines, and distribution needs.
• Assist with regulatory submissions and inspection readiness activities.
• Collaborate to finalize SOPs, batch records, change controls, deviations, and CAPAs.
• Coordinate with Quality, Finance, Procurement and Legal on budgets and vendor deliverables.
• Serve as on-site lead during labeling/packaging campaigns; travel 20–25%.

Conoscenze

Project management

Clinical operations liaison

Communication skills

Formazione

Bachelor’s or Master’s in a scientific discipline

Strumenti

IRT systems

Descrizione del lavoro

Oruka Therapeutics seeks a Senior Manager, Clinical Supply Chain – Biologics to lead global clinical supply activities from planning through execution. The role supports early- to late-stage trials across the US, Canada, and Europe within a fast-paced, cross-functional team.

The hybrid in-office/remote position is based in Waltham, MA, with a strong emphasis on collaboration with Regulatory, Quality, and Clinical Operations to ensure timely, compliant supply and continuous process improvements.