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Program Manager - Quality and Operations

AstraZeneca
Mississauga, ON
Management

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. Do you have expertise in and a passion for global Clinical Program Management? AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. Join a dedicated Oncology team in Haematology that's growing fast and building a strong track record of success. We have multiple indications and many high-quality molecules at all stages of development – but we see even more potential. Following the recent acquisition of Gracell Biotechnologies we are looking to expand our team bringing in individuals with Clinical Operations experience in Heamatology Cell Therapy. Haematology sits within our broader Oncology Research & Development organization. We take an inter-disciplinary approach including novel biomarkers, AI, novel endpoints and cutting-edge trial designs to shape the future of our business and Oncology. With one of the broadest and deepest Oncology pipelines in the industry, there are many opportunities to work with new and novel drugs and help discover what's next. Supportive team players, we draw on diverse knowledge from across the business and external partners to come to bear on the toughest medical challenges. The Global Clinical Operations Program Director (GPD) is a core global role within the Haematology R&D Clinical Operations function. On behalf of the Senior Global Clinical Operations Program Director (Sr GPD), the GPD provides strategic operational leadership and oversight of a suite of global clinical studies within a program covering all clinical operations deliverables, covering all clinical operations deliverables to scope, quality, budget, time, resource and risk, ensuring new innovative design and delivery models are used appropriately. The role involves integrating strategy, design, feasibility and operational planning to produce business-focused clinical drug development programs that align with priorities and strategy. The GPD may provide project leadership for cross-functional clinical submission teams in support of regulatory marketing applications and post-registration product maintenance deliverables. Additionally, the GPD may lead or contribute to improvement and change projects within clinical operations and/or other business areas, as well as potential line management of clinical operations personnel. Bachelor of Science/Master of Science degree in related discipline, or equivalent work experience. PhD, MD, PharmD Experience from within the pharmaceutical industry or similar large multinational Clinical Research organizations. Experience in Oncology Phase 1 dose escalation and/or registrational Phase 3 Haematology Cell Therapy trials as a global study leader or Oncology Program Manager Proven knowledge of project management tools and processes Skilled & experienced in change management Ability to look for and champion more efficient and effective methods/processes of delivering clinical operations components focusing on key performance metrics around reliability, productivity, cost, and quality Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a regional and local environment Excellent stakeholder management skills Line management experience is desirable Experience with development and implementation of digital health initiatives in Clinical Studies 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 . AstraZeneca 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.