Senior Global Clinical Operations Program Director

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.

Join us as a Senior Global Clinical Operations Program Director (Sr GPD) in our Oncology R&D department. This core global role within the Clinical Operations function of Late Stage R&D is accountable to the Global Product Team (GPT) for the operational delivery of the agreed clinical development plan. As a Sr GPD, you will be responsible for program leadership and management of all clinical operations deliverables to scope, quality, budget, time, resource and risk, ensuring new innovative design and delivery models are used appropriately.

What you’ll do:

As a Senior Global Program Director (Sr GPD), your role will be pivotal in steering all clinical program activities. You will ensure that critical issues are promptly surfaced and addressed by the Global Project Team (GPT). Collaborating effectively with the Global Clinical Head (GCH) and the Biometrics Team Leader, you will provide visionary leadership, clear mentorship, and foster shared objectives across the Clinical Project Team (CPT) and clinical delivery teams.

You will play a key role in establishing an efficient team structure and encouraging a collaborative and high-performance culture within the CPT. Your responsibilities also include coordinating the clinical operations components of regulatory submissions, supporting regulatory interactions and reports, and ensuring clinical contributions are inspection-ready.

Typical Accountabilities

• Coordinate all clinical program activities, advancing key issues to the Global Project Team (GPT) and providing clinical operations expertise, including feasibility, country selection, and risk management.

• Collaborate with the Global Clinical Head (GCH) and Biometrics Team Leader to provide leadership and goal alignment for the Clinical Project Team (CPT) and clinical delivery teams.

• Lead clinical development results for the GPT, ensuring strategy, design, and delivery meet scope, quality, budget, and timelines while managing resources and risks.

• Establish team structure and practices to ensure the CPT operates as a high-performing team.

• Line-manage Clinical Operational Leaders both at the Global Study Level and Program Level to support aligned GPT results.

• Ensure integration of clinical operations components in regulatory submissions, including support for regulatory interactions and inspection readiness.

• Act as the primary operational contact for AZ with external partners, leading all aspects of program planning and delivery in collaboration with outsourced partners.

• Align clinical strategy and facilitate product knowledge transfer between early and late-stage organizations.

• Run clinical plans, ensuring timely compliance with company governance controls, including financial oversight and continuous assurance.

• Serve as a critical decision-maker and issue customer concern point with external partners for clinical delivery and lead non-drug project management initiatives like cross-functional improvements.
  

Education, Qualifications, Skills and Experience

• Bachelor of Science/Master of Science degree in a related field, or equivalent work experience; an advanced degree is preferred.

• Extensive global drug development leadership or equivalent leadership experience across various roles.

• Broad experience across the product life cycle, with a focus on late-stage development and ideally experience in multiple therapeutic areas.

• Strong clinical operations knowledge with a proven track record of successful delivery.

• Comprehensive understanding of the clinical and pharmaceutical drug development process.

• Proven track record to develop programs that meet business goals and effectively assess business risk versus potential value, with an understanding of global business requirements.

• Significant experience in program management and the application of project management techniques in sophisticated projects, including resourcing, financial management, and case development.

• Demonstrated ability to build successful collaborations with internal collaborators and external partners.

• Strong strategic influencing skills with the ability to influence broadly within and outside the organization.

• Willingness to travel both domestically and internationally.

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
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Are you interested in working at AZ, apply today!

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.