Clinical Supplies Project Manager (Hiring Our Heroes Corporate Fellow

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.

• 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.

• Bachelor's degree in a scientific, business, or related discipline required; MS/MBA preferred.

• 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…