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Global Study Associate Director, Late Development Oncology Program Management Hybrid Work- on average 3 days/week from office Minimum 1 day from our Mississauga office and 2 days from our Mississauga or Downtown office

At AstraZeneca (AZ), 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. 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. Summary: The Global Study Associate Director (GSAD) is a business critical role within AstraZeneca Late Development Oncology (LDO) whose main accountability is the delivery of clinical studies. The GSAD is responsible for leading a cross functional study team (core and extended) and for providing the team with direction and mentorship to enable successful study delivery. The GSAD is the main liaison between the study team and the Clinical Program Team (staring with study handover through to close out and archiving. Essential Skills/Experience: Lead and support a diverse cross-functional study team to ensure the successful progression of clinical studies, aligning with SOLID (Study Team Operating model for Internal Delivery) and its roles, accountabilities, and responsibilities framework (RACI). Drive the achievement of turning points in adherence to timelines, budget, and quality standards. Facilitate open communication across all functions and provide guidance and support to the core and extended study team members, aligning with the study-specific communication plan. Maintain strong collaboration with the CRO Project Manager as the primary AZ point of contact for outsourced studies, ensuring adherence to timelines, budget, and quality standards. Uphold oversight of the CRO throughout the study lifecycle in accordance with relevant AZ SOPs and guidelines. Contribute to and take responsibility for the development of critical study level documents (e.g., Clinical Study Protocol (CSP) through to Clinical Study Report (CSR)) in alignment with relevant AZ SOPs. Develop and maintain relevant study plans, including input into study level quality and risk management planning, ensuring clear risk response strategies and issue partner concern pathways for the entire study team. Monitor study performance against agreed upon plans, achievements, and key performance indicators, using company tracking systems and project timelines. Communicate any identified risks to timelines and/or quality to the Clinical Project Team (CPT) along with proposed mitigations. Identify and report quality issues within the study, collaborating with all functions to overcome barriers and achieve milestones. Proactively communicate findings and corrective action plans to relevant partners. Oversee Trial Master File (TMF) completion in accordance with relevant AZ SOPs, ensuring ongoing quality control activities to maintain TMF completeness at all times. Ensure timely compliance with company-wide governance controls such as Delegation of Authority, Sunshine Act, budget attestations, and Clinical Trial Transparency. Desirable Skills/Experience: University degree (or equivalent), preferably in medical or biological sciences or subject area associated with clinical research 7 years of relevant clinical experience in the pharmaceutical industry, including 2 years’ project management experience, or equivalent combination of education, training and experience

Extensive knowledge of clinical research regulatory requirements and demonstrated abilities in clinical study management processes and clinical/drug development

Demonstrated solid project management skills and knowledge of relevant tools

Great People want to Work with us Find out why: GTAA Top Employer Award for 10 years

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Ready to make a meaningful difference? Apply today to join our mission to eliminate cancer as a cause of death AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca 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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