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 (G S D) is a business-critical role within the Rare Disease s Development O perations 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 G S D 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 lead s a cross-functional study team by setting direction, own s study level operational decisions, and establish es consistent operational standards for as signed studies . The role is accountable for early study planning , operational strategy development, and ensur es delivery approaches are robust, feasible , and aligned with program objectives . The GSD provide s 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 GS D collaborate s with other internal stakeholders cross-functionally, and/or external partners, to identify , manage and resolve issues affecting s tudy delivery and to ensure an effective partnership and teamwork within the study team and vendors as appropriate . T he G S D also provide s advice and support related to s tudy team leadership, senior stakeholder management, conflict management, etc. The G S D will also lead other non-drug process improvement projects as required . Accountabilities: Study D elivery: T he planning and execution of pivotal, high priority and complex clinical studies and Access to Medicine programs with diverse operating model s ( e.g., internally-led, outsourced, hybrid models) by leading a study team(s) – core and extended , driving achievement of milestones and goals Study D ocuments: Provid es 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 O perational S trategy : Establish es overall strategy and defin es the operational standards and documentation for the assigned Study( ies ) (e.g., study management , oversight and commun ication 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: Develop s , m aintain s , t rack s and forecast s the Study budget that include s 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 – </span