Clinical Supplies Project Manager (Hiring Our Heroes Corporate Fellow)
Merck
Job Overview We are excited to be a sponsor of Hiring our Heroes and proud to offer transitioning service members a unique opportunity to gain valuable professional experience through our 12‑week fellowship program. The Global Clinical Supply (GCS) organization is accountable for managing the 'end‑to‑end' integrated clinical supply chain across the full portfolio of clinical trials. GCS supports more than 300 Phase I‑IV clinical trials run in‑house, 400+ outsourced or run by partners, and 300+ clinical trials. GCS is accountable for the planning, sourcing, labeling, packaging and delivery of clinical supplies to clinical sites across more than 60+ countries, in accordance with US and Global regulations, company policies, and Standard Operating Procedures. The GCS Clinical Planning (Planning) organization is the key interface between clinical development teams and the operational/executional arms within the business. Clinical Supplies Project Managers (CSPMs) are responsible for the translation of global clinical study demand into supply plans and are accountable for all delivery of clinical finished goods materials to initiate trials on time and maintain patient continuity of supply. Responsibilities Work independently to design strategic and operational plans for all activities associated with assigned clinical studies within a given development program (CSPM Protocol Manager) and/or all clinical supplies across an entire compound program (CSPM Program Manager). Serve as the primary protocol‑level GCS point of contact for given protocols to customers both internal and external to GCS and act as the GCS spokesperson at clinical development related meetings. Serve as the primary program‑level GCS point of contact representing the GCS Planning Team to customers both internal and external to GCS and act as the lead GCS spokesperson at clinical development related meetings that impact the clinical program. Interact with various organizations (Clinical Sciences, Study Management, Regulatory, CMC, Pharmaceutical Sciences, Formulation Development, and Global Development Quality) to address drug supply related topics. Use the SAP system to establish a consolidated, visible forecast for all study product needs (Bulk Drug Product and Clinical Finished Goods). Utilize key tools in the planning and managing of clinical supplies for assigned program(s) (Microsoft Project Plans, ADI Logs, forecasting tools). Support the collection of clinical supply chain metrics and identify areas for operational improvement. Initiate non‑Merck marketed drug product planning activities for new protocols. Serve in a support or lead role for clinical supply issue escalation to GCS Leadership. Mentor new team members and support staff development. Participate as a lead business process owner or SME in a particular area of expertise. Champion and drive identified business process improvement initiatives. Participate in Interactive Voice Response (IVR) System development and User Acceptance Testing (UAT) for assigned studies. Oversee all bulk drug supply management and ensure proper allocation of drug product across assigned program(s). Establish timelines for bulk manufacturing needs and release of drug product across assigned program(s). Identify significant supply risks associated with clinical bulk requirements. Manage the clinical supply budget for respective program(s) and support cost estimates requested by Product Development Teams. Chair the Clinical Supply Program Team (CSPT) and negotiate timelines with cross‑functional representatives. Author clinical supply documentation for labeling, packaging, and critical CMC activities. Ensure GCS Planning Leadership is aware of program pipeline forecast to ensure proper resourcing of all levels of planning support. Qualifications Minimum Education Bachelor's degree in a scientific, business, or related discipline required; MS/MBA preferred. Required Experience and Skills At least 8 years of experience in project management. At least 3 years of experience in planning, scheduling, coordination and processing of clinical supply activities, or equivalent. Understanding of MRP systems and demand planning principles. Strong organizational, time‑management and problem‑solving skills. Results oriented with proven ability to execute on collaborative projects and develop subject matter expertise. Exceptional written and verbal communication and relationship skills with high personal integrity, credibility, and energy. Ability to prioritize tasks and initiatives to mitigate supply risks. Advanced proficiency in Microsoft Excel, PowerPoint, and Word. Experience with change management and leading process improvement initiatives. Preferred Experience and Skills Demonstrated ability to negotiate, resolve conflicts and engage in decision making across functional areas. Strong knowledge of project management and clinical customer relationship management principles. Knowledge of drug development, production, distribution, shipping, destruction, and reconciliation processes. Knowledge of order management, supply chain operations, and document control. Experience leading teams and developing direct reports. Familiarity with data analytics/visualization software. Familiarity with SAP as an ERP/MRP system. Familiarity with GMP requirements, quality procedures, and SOP execution. Eligibility This posting is for the Hiring Our Heroes, Corporate Fellowship 2026 - Cohort 3. Candidates must be transitioning service member fellows who will complete the program within the last 180 days of transition from military service. The fellowship will be 12 weeks long. US and Puerto Rico Residents Only. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance. Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. 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. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit the EEOC resources. #J-18808-Ljbffr Merck & Co.
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