Associate Director, Clinical Supply Project Manager - Program (Hybrid)

Company: Merck
Location: Rahway
Posted on: May 1, 2025

Job Description:

Job DescriptionThe Global Clinical Supply (GCS) organization is responsible for managing the end-to-end integrated clinical supply chain across our Company's Research Laboratories portfolio of clinical trials. GCS oversees planning, sourcing, labeling, packaging, and delivery of clinical supplies globally. The GCS Planning organization acts as the key interface between clinical development teams and operational/executional units within the business.The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS contact, representing the GCS Planning organization to both internal and external customers, and acts as the lead GCS spokesperson at clinical and development meetings. The role involves designing strategic and operational plans for all clinical supply activities related to assigned compounds or programs. The incumbent must understand the end-to-end product development process and the connectivity between functions supporting the pipeline, such as clinical development, CMC, supply chain, and human health, while balancing patient needs and ensuring a stable supply of products.Primary activities include, but are not limited to:

• Collaborate closely with key partner organizations (clinical development, regulatory, quality, and supply chain) as the lead GCS Planning program representative to negotiate timelines, strategies, and other topics for all clinical supplies across assigned programs.
• Establish timelines for bulk manufacturing needs and drug product release across assigned programs.
• Work directly in SAP to create consolidated, visible forecasts for all products used within the assigned programs, such as bulk drug products.
• Oversee bulk drug supply management, ensuring proper allocation across studies within the programs.
• Identify significant supply risks related to clinical bulk activities and serve as the lead for clinical supply issue escalation within the program(s), managing these with GCS leadership.
• Manage the clinical supply budget for the respective program(s) and support all protocol and program cost estimates.
• Author documentation supporting labeling, packaging, and supply chain activities, including critical CMC documentation.
• Support collection of supply chain metrics and participate as a subject matter expert in relevant activities.
• Mentor new team members and support staff development.
• Drive continuous improvement initiatives to enhance planning processes and systems.
• Stay updated on industry trends, regulations, and best practices, incorporating them into operations.
• Focus on customers and patients, making rapid and disciplined decisions while demonstrating ethics and integrity.Required Experience and Skills:

• Bachelor's degree in a scientific, business, or related discipline; MS/MBA preferred.
• At least 8 years of project management experience.
• Minimum 5 years in planning, scheduling, and supply chain activities or equivalent.
• Excellent communication and interpersonal skills, with the ability to engage stakeholders at various levels.
• Strong project management knowledge and technical proficiency with supply chain systems (e.g., SAP, Oracle) and Microsoft Office.
• Strong analytical and problem-solving skills.
• Flexibility and adaptability in a fast-paced environment.
• Attention to detail, organization, and multitasking abilities.
• Proactive mindset for continuous improvement.
• Proven project/portfolio management record.
• Knowledge of GMP and GCP is highly desirable.Preferred Experience and Skills:
  • Experience with ERP systems, demand planning tools, and inventory management.
  • Familiarity with data analytics/visualization software.
  • Knowledge of GMP, quality procedures, and SOP execution.
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Keywords: Merck, West Babylon , Associate Director, Clinical Supply Project Manager - Program (Hybrid), Executive , Rahway, New York