Senior Clinical Supply Strategist

1 week ago

Sandton, South Africa Pfizer Full time

Position Purpose

This role will be accountable for activities involved in developing and implementing mid to long term Pfizer supply chain strategies and networks for the Middle East, Russia and Africa (MERA) region. This role will support the Global Clinical Supply regional MERA Lead & Global Clinical Supply (GCS) functional groups, including Innovative Sciences Operations (ISO), Clinical Supply Strategy & Management (CSSM), Clinical Research Pharmacy (CRP), Clinical Supply Operations (CSO) and Strategic and Operations Management (SOM), with business growth & execution of new study programs or initiatives that include Investigational Product (IP) forecast, clarification of country requirements, legislations and policies related to IP strategy (including operational timelines and costs), and coordination for key logistics events, monitoring key performance indicators, analyzing cost/performance data, coordinating cross-functional work teams to increase effectiveness of supply chain logistics initiatives.

This position provides high level and strategic support to ISO, CSSM, CRP, CSO and SOM with regards to clinical supplies strategy setup/maintenance, forecast, processes optimization, logistics, import/export processes and global clinical supply requirements. The primary role of the Clinical Supply Strategist Senior is to serve as the primary point of contact between the GCS functional teams and strategic partners and vendors such as Pfizer Country Offices (PCO), brokers, carriers, warehouse, and domestic distribution providers to ensure safe and secure movement of clinical supplies to patients. This role will serve as Clinical Supply Operations’ primary point of contact (POC) for MERA countries.

The position will also support Pfizer Medical Affairs group across the region with regards to Expanded Access, Compassionate Use & Post-Trial Access programs and Bioequivalence/Bioavailability (BE/BA) studies support for IP strategy setup/maintenance, whenever needed.

The role is accountable to Patients and GCS leaders, for delivering GCS Clinical Supply Logistics and Regional Operations activities with regards to planning, cost effectiveness and timely delivery of high quality clinical supplies. The role will proactively ensure quality and compliance through risk identification and mitigation plans, strategic planning and execution, and overall design input on a program and protocol basis.

This position, having a direct reporting relationship to ISO, will ensure compliant and effective IP related activities and projects by interacting with Pfizer GCS Lines (e.g., ISO, CSSM, CRP, CSO, SOM, Quality Assurance [QA]), other strategic Pfizer partner lines (e.g., Global Chemistry Manufacturing Controls [CMC], Worldwide Safety & Regulatory [WSR], Medical Affairs, Corporate Affairs, Pharmacovigilance, Global Product Development [GPD], Pfizer Global Supply [PGS], Finance, Corporate Pricing, Business Units, etc.), and external partners and vendors (e.g., PCO, preferred customs brokers, distribution service providers, carrier service providers and Study Management Partners - Clinical Research Organizations [CRO]), to support strategic clinical supplies initiatives and develop the establishment of regional procedures.

Primary Responsibilities
- Serve as the primary point of contact between the GCS organization and strategic partners and vendors to ensure safe and secure movement of clinical supplies to patients in the region.
- Lead the development and optimization of import/export processes in MERA.
- Ensure compliant and effective import/export activities by interacting with Pfizer GCS Lines, other strategic Pfizer partner lines, and external vendors to drive strategic import/export initiatives and develop the establishment of clear procedures in the region.
- Assist the GCS Regional MERA Lead in clinical supplies initiatives and supportive projects in the region (e.g. Expanded Access program strategy, Regional countries setup, MERA Operational Review meeting, Metrics report, etc).
- Assist Pfizer Medical Affairs in supplies initiatives and supportive projects in MERA (e.g., Post-Trial Access, Compassionate Use, Expanded Access, BE/BA studies management, etc).
- Assist GCS in clinical supplies initiatives and supportive projects in the region, when needed (e.g., Process Mapping & Optimization, Best Practices, Digital Clinical Supply Chain, etc).
- Drive local support for Pfizer Regulatory Affairs, GPD and external partners (CRO) in Clinical Trial Application (CTA) by being accountable for reviewing IP related documentations (drug supply description, forecast, manufacture information, etc) for quality and compliance purposes before MoH submission.
- Assist Pfizer Regulatory Affairs and/or external partners (CRO) with Import License (IL) umbrella review and validation (drug supply forecast) for quality and compliance purposes, whenever needed.
- Drive Regional support for CSO and ISO activities in MERA.
- Ensure that th

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