Development Director

5 days ago

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

Pfizer Research & Development is the driving force behind our innovative product pipeline, dedicated to delivering life-changing medicines to the world.


Job Summary:
Regular, full-time

The Expanded Access and Grant Director reports to the CSSM Group Director in Clinical Supply Strategy and Management (CSSM).

CSSM is a high-performing team within Pfizer's Global Clinical Supply (GCS) unit, striving to deliver best-in-class clinical supply strategies, including 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 top priority, and CSSM aims to employ the highest quality standards across our clinical supply solutions.

As part of an innovative clinical supply chain, we continuously challenge the status quo to optimize our systems and processes.

The role of the Expanded Access and Grant Director (EAGD) 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.

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 skills, risk mitigation, initiative-taking project and time management skills to meet program and study deliverables.

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

Operate as a key member of the EAGD 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, including 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.

~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 empowers colleagues to design their workdays for maximum productivity, work-life balance, and innovation.

Currently, our employees are expected to be on-site days per week, blending on-site collaboration and connection with off-site remote working when it makes business sense to do so.

At Pfizer, we value diversity and inclusion for innovation and growth.

We are committed to building inclusive teams and an equitable workplace for our employees to bring their true selves to work.

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