Role Summary
The Operational Strategy Lead (OSL) is a member of Global Clinical Supply Operations (GCSO) within the Clinical Development & Operations group. The role involves developing and implementing end‑to‑end clinical supply strategies for Pfizer’s clinical programs and studies, ensuring quality, compliance, and patient‑centered delivery of packaging, labeling, and distribution solutions.
Key Responsibilities
* Develop and execute mid‑to‑long term supply‑chain strategies for assigned clinical programs, including forecasting and execution of key packaging, labeling, distribution, and logistics events.
* Monitor and evaluate the effectiveness of strategies, partnering with Clinical Supply Operations lines to ensure seamless implementation and delivery of clinical supplies.
* Represent GCSO on the Clinical Supply Team (CST) for assigned programs, ensuring overarching strategy & scenario planning is shared with appropriate stakeholders.
* Provide input to GCSO level program/protocol dashboards and support program management activities.
* Directly oversee GCSO activities (clinical packaging, labeling operations, and trial distribution) to meet study timelines.
* Ensure GCSO inspection readiness as part of program support.
* Lead or participate in GCSO strategic and continuous improvement initiatives.
* Provide program‑level forecasts and special needs to vendors, and estimate packaging, labeling, and distribution/storage costs.
* Support integration activities and fiscal accountability by refining project‑specific costs.
* Ensure compliance with legal requirements (EHS, cGMP, GCP, import/export, quality standards, 21 CFR Part 11) and maintain training and compliance for the role.
* Interface directly with GCS and other groups across Pfizer to provide guidance and resolve issues related to clinical packaging and distribution activities.
* Collaborate with Supply Chain Leaders (SCL) and Clinical Research Pharmacists (CRP) to develop practical packaging designs for clinical supplies and coordinate packaging & labeling requirements with contract packaging organizations.
* Develop positive partnerships with key stakeholders, proactively manage risks, and contribute to improving operational strategy using technology and industry trends.
Work Location
Hybrid
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating diversity and supporting all employees. We are a Disability Confident Employer and will make reasonable adjustments to support your application and future career.
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