Senior Manager, Clinical Supply Chain & IRT Operations

BeOne Medicines; San Mateo (CA); On-site; USD 150,000 - 230,000; Full time

Job summary

BeOne Medicines is seeking a Manager/Senior Manager, Clinical Supply Chain to lead drug supply activities for one or more clinical studies. The role focuses on planning, label development, packaging, and distribution, ensuring continuous supply to patients while reducing risk and waste.

You will manage relationships with internal stakeholders and external partners, leverage IRT systems, and improve processes in a cGMP environment.

Qualifications

• Bachelor or Master degree in business administration, operations management, or similar.
• 7+ years of progressive experience in clinical supply chain, preferably biotech/pharma/CRO.
• Experience with cGMP environments and IRT systems.
• Ability to lead cross-functional projects and drive process improvements.

Responsibilities

• Represent the Clinical Supply Chain on CST and provide a high service level to internal stakeholders (Clinical Operations, Regulatory, Quality, CMC).
• Create supply and inventory plans and develop production schedules for clinical trial materials.
• Monitor schedule adherence and adjust production plans as needed.
• Manage GMP inventory, expiry, and drug accountability.
• Oversee daily activities for FG label & pack CMOs and distribution vendors.
• Investigate exceptions, determine root causes, implement CAPAs and drive closure.
• Ensure label text and proofs comply with rules, regulations, product specs, and study protocols.
• Support IRT testing and develop IRT supply strategy; oversee ongoing supply activities in system.
• Coordinate and track bulk shipments to CMOs, depots, and vendors; maintain import licenses.
• Develop strategies to maximize supply efficiency and minimize waste; identify risks and mitigations.
• Lead cross-functional projects and create/update SOPs.

Skills

Clinical supply planning

Stakeholder management

Cross-functional leadership

Risk mitigation

Drug supply chain knowledge

Education

Bachelor or Master Degree in Business Administration/Operations Management

7+ years of clinical supply chain experience

Tools

IRT systems

CAPA tools

Job description

BeOne Medicines is seeking a Manager/Senior Manager, Clinical Supply Chain to lead drug supply activities for one or more clinical studies. The role focuses on planning, label development, packaging, and distribution, ensuring continuous supply to patients while reducing risk and waste.

You will manage relationships with internal stakeholders and external partners, leverage IRT systems, and improve processes in a cGMP environment.