Expanded Access and Grant Lead

4 months ago

Mississauga, Canada Pfizer Full time

Posting closing date: September 5 2024

Date de fin d’affichage : le 5 septembre 2024

Status : Regular, full-time

Statut :Régulier, temps plein

(Français à suivre)

ROLE SUMMARY

The Expanded Access and Grant Lead reports to the CSSM Group Lead in Clinical Supply Strategy and Management (CSSM). CSSM is a well-established high performing team within Pfizer's Global Clinical Supply (GCS) unit striving to deliver best in class clinical supply strategies providing supply forecasting, investigational product packaging and labeling, and overall project management in support of Pfizer's dynamic investigational product portfolio. The patients we serve are our number one priority and CSSM aims to employ the highest quality standards across our clinical supply solutions. As part of an innovative clinical supply chain, we routinely challenge the status quo in efforts to optimize our systems and processes.

The role of the Expanded Access and Grant Lead (EAGL) is to 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. The EAGL translates supply demand into effective supply chain strategies. This strategy is reflected in operating plans, inclusive of scope, time, cost, risk, and communication plans which balance the needs of the study sponsors and expanded access patients. This work requires individuals to be change agile and demonstrate effective decision making skill, risk mitigation, initiative-taking project and time management skills to meet program and study deliverables.

Responsibilities include the following:

- Lead the development and execution of investigational material supply strategies for moderate to complex non-Pfizer sponsored studies and Expanded Access programs.
- 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 across assigned program(s) ensuring dosing continuity and supply availability for study participants 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 logístical 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.
- 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.

Basic Qualifications:

- B.S. degree (or equivalent) required.
- 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 experience leading and delivering in a matrix or cross functional team environment
- Demonstrated understanding of pharma quality and regulatory framework

Preferred Qualifications:

- Proven ability to effectively develop, communicate, and execute project plans with multiple stakeholders.
- 5+ years of experience within supply chain management, clinical research and or pharmaceutical sciences.

We are proud to offer employees a flexible working model that is grounded on empowering colleagues to design their workdays so that they can maximize their productivity, enhance their work-life balance and support a way of working that fosters innovation and patient-centricity. Currently, our employees are expected to be on-site 2.5 -3 days per week blending on-site collaboration and connection with off-site remote working when it makes business sense to do so.
- The annual base salary for this position ranges from _$64,500 to $107,500_._
- Leader - Accès élargi et subventions

RÉSUMÉ DU POSTE

Le ou la leader - Accès élargi et subventions relève de la personne responsable du groupe Gestion et stratégie d’approvisionnement des fournitures cliniques. Cette équipe très performante et bien établie au sein de l’unité d’Approvisionnement mondial, Fournitures cliniques (AMFC) de Pfizer se consacre à mettre en place les meilleures stratégies d’approvisionnement clinique. Pour ce faire, elle établit des prévisions en matière d’approvisionnement, veille au conditionnement et à l’étiquetag

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