Job Information
BeOne Medicines Associate Director, Clinical Supply Chain in San Mateo, California
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.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.