Associate Director, Clinical Supply Project Manager - Protocol - Hybrid

Overview The Global Clinical Supply (GCS) organization manages the end-to-end integrated clinical supply chain across the company’s research laboratories. The Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans for all activities associated with clinical supplies for assigned studies. Responsibilities Participate as key stakeholder on the Clinical Trial Teams and collaborate closely with other functional areas to negotiate timelines and strategy for clinical supplies. Interact with partner organizations such as clinical development, regulatory, quality, and supply chain to address clinical supply or change‑management topics. Establish timelines for clinical supply needs per study and signal sourcing, manufacturing, packaging, and distribution requirements. Analyze and anticipate project risks related to clinical supply chain deliverables, preparing mitigation strategies for review with partners and leaders. Lead or participate in cross‑functional initiatives and projects, utilizing tools such as IRT, Microsoft PowerApps, SWMS, Veeva, MEDS, MyLearning, and other Microsoft Applications. Work in the SAP system to create a consolidated, visible forecast for all study product needs (Bulk Drug Product and Clinical Finished Goods). Author clinical supply documentation for labeling and packaging, and supply chain documentation for critical CMC activities. Prepare the Clinical Supplies section of the study protocol and present supply information at investigator meetings. Support collection of clinical supply chain metrics and participate in critical non‑pipeline activities. Participate in Interactive Voice Response (IVR) System development and User Acceptance Testing (UAT) for assigned studies. Initiate and process change controls in collaboration with GCS Planning, following GCS planning SOPs/BPs and QMS procedures. Author and process deviation records, and support deviation investigations as required. Support regulatory agency inspections for assigned trials and engage in non‑pipeline compliance activities (e.g., process improvement initiatives, SOP/BP development, cross‑functional projects). Demonstrate high capability to solve unstructured problems, make informed risk decisions, and influence portfolio decisions with facts and data. Balance strategy with tactical execution, demonstrating ownership and accountability of assigned work. Focus on customers & patients, make rapid disciplined decisions, and uphold ethics & integrity. Qualifications Bachelor’s degree in a scientific, business, or related discipline (MS/MBA preferred). At least 8 years of experience in project management. At least 5 years of experience in planning, scheduling, coordination, and processing of supply chain activities. Excellent communication and interpersonal skills, including negotiation, influencing, and relationship‑building. Strong knowledge of project management principles and clinical customer relationship management. Technical proficiency with supply chain systems (e.g., SAP, Oracle), demand planning principles, and Microsoft Excel, PowerPoint, Word. Strong analytical and problem‑solving skills; ability to analyze complex data and make data‑driven decisions. Flexibility and adaptability to thrive in a fast‑paced, dynamic environment. Detail‑oriented and organized with strong multitasking and prioritization skills. Continuous improvement mindset and proven record in project/portfolio management. Knowledge of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) is highly desirable. Preferred Experience and Skills Proficiency in using supply chain management systems, including ERP systems (SAP), demand planning tools, and inventory management systems. Familiarity with data analytics/visualization software. Experience with GMP requirements, quality procedures, and SOP execution. Equal Employment Opportunity Statement As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. We comply with all affirmative action requirements and maintain a diverse and inclusive workplace. Salary and Benefits Salary range: $142,400.00 – $224,100.00. Eligible for annual bonus and long‑term incentive, if applicable. Comprehensive benefits include medical, dental, vision, retirement (401(k)), paid holidays, vacation, and compassionate and sick days. #J-18808-Ljbffr MSD Malaysia