Clinical Supplies Project Manager; Our Heroes Corporate Fellow

Job Requirements

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.

Working independently, the CSPM designs strategic and operational plans for all activities associated with their assigned clinical studies within a given development program (CSPM Protocol Manager) and/or all clinical supplies across an entire compound program (CSPM Program Manager). The incumbent is expected to have a strong understanding of drug development, clinical research, and/or clinical supply chain, as well as interpersonal skills with a demonstrated ability to negotiate with key stakeholder groups and drive/influence results in a dynamic environment.

The CSPM Protocol Manager serves as the primary protocol-level GCS point of contact for given protocols to customers both internal and external to GCS and serves as the GCS spokesperson at clinical development related meetings (i.e., Clinical Trial Teams) and product development related meetings.

The CSPM Program Manager serves as the primary program-level GCS point of contact representing the GCS Planning Team to customers both internal and external to GCS and serves as the lead GCS spokesperson at clinical development related meetings that impact the clinical program (i.e. Clinical Supply Program Team, Clinical Development Sub-Team) as well as product development related meetings.

Primary activities include, but are not limited to:
General

Activities:

• Interacts with various organizations, as a lead GCS Planning program representative, such as Clinical Sciences and Study Management (CSSM), Regulatory, CMC, Pharmaceutical Sciences, Formulation Development, and Global Development Quality as necessary to address drug supply related topics.
• Works directly in the SAP system to establish a consolidated, visible forecast for all study product needs (Bulk Drug Product and Clinical Finished Goods).
• Responsible and accountable for utilizing key tools in the planning and managing of clinical supplies for assigned program(s). This may include Microsoft Project Plans, Actions, Issues and Risk (ADI) Logs, forecasting tools (SAP), etc.
• Support the collection of clinical supply chain metrics to describe business health and the identification of areas for operational improvement.
• Responsible for initiating non‑Merck marketed drug product planning activities for new protocols
• Serves in a support or lead role for clinical supply issue escalation to GCS Leadership (as issue owner or in support of other CSPMs that support assigned programs)
• Mentors new team members and supports staff development, as needed
• Participates as a lead business process owner or SME in a particular area of expertise.
• Champions and drives identified business process improvement initiatives, as needed.

• Participates as a key stakeholder on the Clinical Trial Teams (CTT) and collaborates closely with other functional area representatives to negotiate timelines and strategy for clinical supplies.
• Responsible and accountable for establishing the timelines for clinical supply needs per…