Global Study Director-Cell Therapy

AstraZeneca; Mississauga; On-site; CAD 105,000 - 140,000; Full time

Job summary

A leading biotechnology company is seeking a Global Study Director (GSD) to lead cross-functional study teams and manage clinical trials, particularly in Oncology. The role involves project management, team mentoring, and close collaboration with external providers to ensure operational excellence. Candidates should possess a relevant university degree and significant experience in clinical trials. AstraZeneca prides itself on a collaborative culture and is committed to employee development and sustainability.

Benefits

GTAA Top Employer Award

Top 100 Employers Award

Canada’s Most Admired Corporate Culture

Qualifications

• At least 7 years of clinical trial experience required.
• Expertise in Oncology clinical trials needed.
• Proven project management experience mandatory.

Responsibilities

• Lead and coordinate cross-functional study teams for clinical trials.
• Provide operational oversight and expertise in development of study documents.
• Ensure studies are inspection-ready at all times.

Skills

Project management

Clinical trial management

Vendor oversight

Oncology expertise

Team leadership

Education

University degree in medical or biological sciences

Job description

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 and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm, and connect on key projects.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet, and our business are interconnected, which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

The GSD is responsible for providing expert input, guidance, direction, mentoring, and support to GSADs on all study-related operational activities within Cell Therapy. The GSD will also provide advice and support to GSADs (Global Study Associate Director) related to study team leadership, senior partner management, conflict management, etc. GSDs will also lead other non-drug programs and improvement projects as required.

1. Lead and coordinate a cross-functional study team of experts in accordance with SOLID and its roles, accountabilities, and responsibilities framework (RACI) to ensure the clinical study progresses as planned, driving achievement of milestones according to timelines, budget, and quality standards.
2. Contribute to vendor/ESP selection activities, including bid defense, and lead operational oversight to ensure appropriate control over the vendor identification and selection.
3. Collaborate with other functions to establish strategies and identify harmonies sought at growing efficiency of global study teams (core and extended).
4. Provide operational expertise into and hold accountability for the development of crucial study-level documents (i.e., Clinical Study Protocol (CSP) through to Clinical Study Report (CSR)) in accordance with relevant AZ SOPs.
5. Ensure all external service providers (i.e., central laboratories, IXRS, ePRO, etc.) are performing to contracted goals and timelines/budget, with adequate oversight documented through planning & control activities.
6. Develop and maintain relevant study plans (e.g., global study management plan and its components such as study project plan SPP), including input into study-level quality and risk management planning (e.g., risk-based quality management, proactive risk and contingency plans), ensuring clear risk response strategies and issue pathways for the entire study team.
7. Be responsible for study-level performance against plans, achievements, and key performance indicators (critical metrics, quality, and operational) using company tracking systems and project timelines (e.g., SPP, data flow metrics dashboard, CTMS or eTMF dashboard), communicating risks and proposed mitigations to CPT.
8. Identify and report quality issues within the study per AZ SOPs, collaborating with all functions to overcome barriers and achieve breakthroughs; proactively communicate findings and CAPAs to relevant partners (e.g., CPT, quality assurance staff, functional line management).
9. Oversee Trial Master File (TMF) completion in accordance with AZ SOPs, including ensuring the TMF plan and Expected Document List (EDL) are in place.
10. Ensure timely compliance with company governance controls (e.g., Delegation of Authority, Sunshine Act, financial attestations, Clinical Trial Transparency).
11. Manage study budget re-forecasting following initial estimates, and oversee study budget management throughout its lifecycle, providing progress reports and financial risk mitigation plans.

Typical Accountabilities

1. Ensure studies are inspection-ready at all times, according to ICH-GCP and AZ SOPs. The GSD is the primary CTCO Clinical Operations contact during audits or inspections.
2. Provide regular performance feedback to study team members and line managers to support professional development.
3. Guide, train, mentor, and support less experienced GSL colleagues continuously.
4. Lead non-drug project work, such as process improvements or leading improvement projects as discussed with their manager.

Education, Qualifications, Skills, and Experience

• University degree (or equivalent), preferably in medical or biological sciences or related fields in clinical research.
• Proven project management experience and training.
• At least 7 years of clinical trial experience.
• Experience in global study leadership and team management.
• Expertise in Oncology clinical trials.
• Extensive knowledge of ICH-GCP guidelines, regulatory requirements, and experience across all phases of clinical studies: startup, maintenance, and close-out.
• Thorough understanding of the cross-functional clinical trial process, e.g., data flow.
• Experience in external provider oversight and management.

Great People want to Work with us! Find out why:

• GTAA Top Employer Award for 10 years
• Top 100 Employers Award
• Canada’s Most Admired Corporate Culture
• Learn more about working with us in Canada
• View our YouTube channel

Interested in working at AZ? Apply today!

AstraZeneca is an equal opportunity employer committed to diversity and inclusion, providing a workplace free from discrimination. We accommodate persons with disabilities upon request. For assistance, email [e-mail].

Date Posted: 11-Jul-2025

Closing Date: 24-Jul-2025

AstraZeneca embraces diversity and equality of opportunity, building an inclusive team with broad perspectives. We welcome applications from all qualified candidates, regardless of characteristics, and comply with all applicable non-discrimination laws and regulations.