Expanded Access and Grant Lead

1 week ago

Mississauga, Ontario, Canada Pfizer, S.A. de C.V Full time $64,500 - $107,500
About the Role

Pfizer, S.A. de C.V is seeking a highly skilled and experienced professional to fill the position of Expanded Access and Grant Lead in our Clinical Supply Strategy and Management (CSSM) team.

Key Responsibilities
  • Develop and Execute Investigational Material Supply Strategies

Lead the development and execution of investigational material supply strategies for moderate to complex non-Pfizer sponsored studies and Expanded Access programs.

Ensure Investigational Material Supply Continuity

Proactively ensure investigational material supply continuity from pack/label to shipment for assigned expanded access programs and non-Pfizer sponsored studies.

Develop and Maintain Aggregated Investigational Supply Forecast

Develop and maintain aggregated investigational supply forecast across assigned program(s) ensuring dosing continuity and supply availability for study participants and expanded access patients.

Calculate and Communicate Cost Estimates

Calculate and communicate cost estimates for GCS provisioning, management, and movement of investigational material.

Operate as a Key Member of the EAGL Team

Operate as a key member of the EAGL team, proactively recognizing and addressing logistical and regulatory issues associated with maintaining continuity of supply.

Partner with the Program Supply Chain Lead

Partner with the program Supply Chain Lead (SCL) to communicate program level investigational material demand for assigned expanded access programs and non-Pfizer sponsored studies to ensure supply provision and continuity.

Requirements
  • Bachelor's Degree (or Equivalent)

B.S. degree (or equivalent) required.

Experience in GMP/GCP Environment

Exposure to working in a GMP / GCP environment and with regulatory audit teams.

Drug Development and Clinical Study Design Experience

Drug development, clinical study design including scientific research, or pharmaceutical manufacturing/packaging/labeling experience.

Stakeholder Matrix Management

Stakeholder matrix management of multi-disciplinary teams that includes project management, negotiation, decision making, conflict management, and process improvement.

Change Management

Change management in a dynamic, complex, and regulated environment.

Leadership and Delivery Experience

Demonstrated experience leading and delivering in a matrix or cross functional team environment.

Pharma Quality and Regulatory Framework

Demonstrated understanding of pharma quality and regulatory framework.

Preferred Qualifications
  • Project Planning and Execution

Proven ability to effectively develop, communicate, and execute project plans with multiple stakeholders.

Supply Chain Management Experience

5+ years of experience within supply chain management, clinical research and or pharmaceutical sciences.

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