Associate Director, Clinical Supply Chain at BeOne Medicines — Remote

General Description:

• Defines and leads the development of program and/or clinical trial supply within Global Supply Chain, with responsibility for strategic and/or tactical planning and alignment with broader organizational goals
• Apply deep knowledge of clinical supply chain areas to provide expert input and guidance on supply capability and feasibility to enable timely and effective execution of clinical trials.
• Actively develops and oversees supply plans to ensure accurate and continuous supply to patients while reducing risk and minimizing waste.
• Manages or oversees drug supply activities related to planning, label development, label & pack, and distribution for one or more clinical programs and/or studies.
• Represents Clinical Supply Chain to internal stakeholders and manages relationships with external supply partners.
• Applies a working knowledge of clinical supply best practices, IRT systems, as well as experience working within a GxP environment to deliver on time and in full high quality clinical IMPs.
• Has a passion for continuous improvement and works with management to develop and implement process improvements to build the organization for the future.

Essential Functions:

• Represent the Clinical Supply Chain on cross functional project meetings such as; Clinical Demand and Operations Planning (CD&OP), Development Core Teams (DCT)
• Represent on Clinical Study Teams (CST) and program development teams and provide a high service level to internal stakeholders (e.g. Clinical Operations, Regulatory, Quality, CMC).
• Provide managerial support to employees with the overall responsibility of leading, training, and mentoring for effective performance.
• Work with Clinical Operations to understand clinical demand requirements and ensure alignment with study teams to supply plans and timelines.
• Develops strategies for inventory plans and ensures production schedules for clinical trial materials are on track.
• Monitor and oversee schedule adherence of production schedules and make course corrections if needed.
• Oversee GMP inventory throughout the supply chain, develop inventory reports, manage upcoming expiry, and ensure drug accountability.
• Oversee daily activities for finished goods FG label & pack CMOs and distribution vendors with internal stakeholders.
• Responsible for investigation of exceptions to determine root causes, implement CAPAs and drive closure.
• Ensure label text and proofs are in accordance with applicable rules, regulations, product specifications, and clinical study protocol(s).
• Develops IRT supply strategy and oversee ongoing supply activities in system and inputs for system builds.
• Develop supply strategies to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans
• Prepare and manage the Clinical Supply Chain functional budget for studies/programs.
• Lead cross functional projects and process improvements related to drug supply.
• Create and/or revise process documents such as Standard Operating Procedures.
• Additional responsibilities as required.

Supervisory Responsibilities:

• Manage and mentors direct reports. Direct reports may reside at locations other than your base location.

Education / Experience Required:

• Bachelor or Master Degree in Business Administration, Operations Management, or similar education required.
• 8+ years of progressive experience in Supply Chain preferably within the biotech, pharmaceutical, CRO, industry. People leadership and development experience preferred.

Global Competencies

Salary Range: $138,500.00 - $188,500.00 annually