Global Study Director (GSD)

Job Title: Global Study Director (GSD)
Location: Mississauga, Canada
At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe.
Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.
As AstraZeneca continues to put patients at the forefront of our mission, we are excited for our move to Kendall Square/Cambridge in 2026. Find out more information here: Kendall Square Press Release
Introduction to Role:
The Global Study Director (GSD) is a business-critical role within the Rare Diseases Development Operations whose main accountability is the operational planning and delivery of high priority and complex clinical studies and Access to Medicine programs studies within a drug program or across program, that are deemed most critical to the business.
The GSD is responsible for study delivery according to the agreed upon operating model, timelines, budget and quality standards; current clinical trial regulations (e.g., ICH GCP, GVP), AZ Standard Operating Procedures (AZ SOPs), AZ policies and established operating guidance; and in line with AZ values and behaviors.
The GSD leads a cross-functional study team by setting direction, owns study level operational decisions, and establishes consistent operational standards for assigned studies. The role is accountable for early study planning, operational strategy development, and ensures delivery approaches are robust, feasible, and aligned with program objectives. The GSD provides expert operational input into study designs; guidance, mentoring, and support to GSADs, GSMs, and GSAMs to strengthen planning and execution quality, decision making and execution disciplines.
The GSD collaborates with other internal stakeholders cross-functionally, and/or external partners, to identify, manage and resolve issues affecting study delivery and to ensure an effective partnership and teamwork within the study team and vendors as appropriate.
The GSD also provides advice and support related to study team leadership, senior stakeholder management, conflict management, etc.
The GSD will also lead other non-drug process improvement projects as required.
Accountabilities:
Study Delivery: The planning and execution of pivotal, high priority and complex clinical studies and Access to Medicine programs with diverse operating models (e.g., internally-led, outsourced, hybrid models) by leading a study team(s) – core and extended, driving achievement of milestones and goals
Study Documents: Provides operational leadership and accountability for the quality, feasibility, and operational integrity of essential study documents from clinical study protocol through clinical study report, ensuring alignment with study strategy and delivery standard.
Study Operational Strategy: Establishes overall strategy and defines the operational standards and documentation for the assigned Study(ies) (e.g., study management, oversight and communication plans, risk mitigation strategy, feasibility assessment, and oversight of operational vendors (e.g., monitoring, labs, imaging, etc.) in collaborations with relevant functions (e,g, rCDI, COM, GSS, etc).
Study Budget: Develops, maintains, tracks and forecasts the Study budget that includes short and long-range forecasting and monthly accruals based on study activities to support program financial goals, resources (allocation) and timelines for the Study against agreed goals
Study Performance Management – Oversees, tracks, and interprets study performance against plans, milestones, KPIs and benchmarks; owns study-level risk and delivery decisions; and communicates risks and mitigations, trade-offs, and recommended actions to senior management.
Vendor and CRO Oversight - Contributes to vendor identification and selection including bid defense, acts as the primary sponsor point of contact, ensures documented oversight per relevant SOPs and guidelines, and drives vendor performance
Quality and Inspection Readiness: Ensures compliance with the International Conference on Harmonization - Good Clinical Practice (ICH-GCP), - Good Pharmacovigilance Practice (-GVP) and EU Clinical Trial Directive, Access to Medicine regulations, throughout the entire development spectrum. Identifies and reports study quality issues and collaborates cross-functionally to implement CAPAs.
Clinical Data: Develops in-depth knowledge of clinical data and ensures