Clinical Supplies Project Manager; Our Heroes Corporate Fellow

Responsibilities

• Translate global clinical study demand into supply plans; ensure on-time delivery of clinical finished goods to initiate trials and maintain patient continuity of supply.
• Design strategic/operational plans for assigned protocols (Protocol Manager) and/or compound programs (Program Manager).
• Act as primary GCS point of contact/spokesperson for clinical development meetings; negotiate clinical supply timelines and strategy.
• Interact with Clinical Sciences/Study Management, Regulatory, CMC, Pharmaceutical Sciences, Formulation Development, Quality to address drug supply topics.
• Build consolidated SAP forecasts for bulk drug product and clinical finished goods; use planning/risk tools (e.g., SAP, Microsoft Project, ADI logs) and collect clinical supply chain metrics.
• Initiate non-marketed drug product planning for new protocols; elevate supply issues and mentor team members.
• Protocol Manager: author Clinical Supplies protocol section; prepare Investigator Meeting materials; manage IVR system development/UAT.
• Program Manager: oversee bulk drug supply management/allocation; set bulk manufacturing/release timelines; manage supply risks/budget; chair CSPT and author labeling/packaging and CMC-support documentation.

• Bachelor's degree (scientific/business/related); MS/MBA preferred.
• 8+ years project management; 3+ years clinical supply planning/scheduling/coordination.

• MRP/demand planning knowledge; strong organization/time management/problem solving; ability to prioritize to mitigate supply risks.
• Advanced Excel/PowerPoint/Word; change management and process improvement.

• Negotiation/conflict resolution; drug development and supply chain/document control knowledge; GMP/SOP familiarity; SAP; leading teams.