Global Clinical Supply Operations Lead

1 week ago

Mississauga, Ontario, Canada Pfizer Full time
About the Role

The Expanded Access and Grant Lead will provide matrix leadership and project management for the provision of clinical supplies distributed by Global Clinical Supply (GCS) for clinical studies and expanded access programs involving investigational research medicinal product.

Key Responsibilities
  • Provide strategic leadership and project management for the provision of clinical supplies distributed by GCS.
  • Develop and implement operating plans, inclusive of scope, time, cost, risk, and communication plans, which balance the needs of study sponsors and expanded access patients.
  • Calculate and communicate cost estimates for GCS provisioning, management, and movement of investigational material.
  • Operate as a key member of the EAGL team, proactively recognizing and addressing logistical and regulatory issues associated with maintaining continuity of supply.
  • Act as a member of the Clinical Supply Team (CST) with a network of partners (internal and external) to ensure GCS meets customer expectations and prioritizes patient safety.
  • Exposure to working in a GMP / GCP environment and with regulatory audit teams.
  • Drug development, clinical study design including scientific research, or pharmaceutical manufacturing/packaging/labeling experience.
  • Stakeholder matrix management of multi-disciplinary teams that includes project management, negotiation, decision making, conflict management, and process improvement.
  • Change management in a dynamic, complex, and regulated environment.
  • Demonstrated understanding of pharma quality and regulatory framework.
  • Proven ability to effectively develop, communicate, and execute project plans with multiple stakeholders.
Requirements
  • 5+ years of experience within supply chain management, clinical research and or pharmaceutical sciences.
  • Strong leadership and project management skills.
  • Excellent communication and stakeholder management skills.
  • Ability to work in a dynamic, complex, and regulated environment.
  • Demonstrated understanding of pharma quality and regulatory framework.

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