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 appropriate transfer of that knowledge to cross-functional study teams to achieve operational excellence.

Team Leadership and Health: Guides, trains, supports, and provides oversight to Global Study Leads/Managers (GSADs, GSMs and GSAMs) assigned to related Study. Provides regular feedback on individual performance and their line managers,

Governance and Compliance: Represents Clinical Operations at study-level governance forums, leads study-level governance interactions, ensures decision clarity and follow-through, and maintains compliance with Delegation of Authority, financial attestations and clinical transparency requirements.

Functional Operational Excellence: Leads or contributes to functional excellence efforts and initiatives within Development Operations, and/or cross- functional process improvement projects, as requested.

Essential Skills/Experience:

Bachelor’s degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development.

>10 years of clinical research experience with demonstrated clinical trial experience, 7 of which in leading roles accountable for study delivery including planning, execution and reporting of global studies of diverse development phases (I – IV)  

For relevant role, >5 years experience in early access and/or post-trial access programs with solid understanding of relevant regulations and operational best practices

Solid understanding of integrated development/life cycle management process for pharmaceuticals products.

Extensive knowledge of ICH-GCP guidelines and clinical research regulatory requirements

Ability to lead cross-functional teams and to represent clinical operations in relevant forums.

Proven excellent, project, resource, and stakeholder management, problem-solving, decision-making and communication skills

Ability to manage multiple competing priorities

Extensive experience in external provider oversight and management

Demonstrated ability to lead and develop other study team members, providing mentorship, direction, and challenge while maintaining effective working relationships within a cross-functional team and senior stakeholders and managing conflict.

Desirable Skills/Experience:

Advanced degree (Master’s or higher) is highly desirable.

PMP certification desirable.

Extensive experience for financial oversight of a global clinical studies is desirable.

~2 years of direct Rare diseases experience

Experience with Project Management software solutions

Experience in leveraging, utilization and/or developing AI tools

Where can I find out more?

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Learn more about Alexion at www.alexion.com

At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives.Ready to lead and inspire? Apply now and take the first step towards a fulfilling career at Alexion, AstraZeneca Rare Disease.

Alexion embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. Alexion is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com .

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Annual base salary for this position ranges from 151,884.00 to 199,347.75. AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs.  In some cases, offers outside the range may also be considered to address unique circumstances.

In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role).  Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks’ paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.

We are using AI as part of the recruitment process.

This advertisement relates to a current vacancy.