Program Manager, Quality Operations
3 weeks ago
Senior Global Clinical Operations Program Director
Location: Mississauga, ON (hybrid 3 days/week in office). 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.
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.
You will partner effectively with the Global Clinical Head (GCH) and the Biometrics Team Leader to provide leadership, clear direction and aligned goals to the CPT members/clinical delivery teams. Additionally, you will be accountable for the clinical operations component deliverables of regulatory submissions, providing support for regulatory interactions and reports and clinical contributions to inspection readiness. Effectively partner with the Global Clinical Leader and Global Project Statistician to provide clear direction and shared goals
Deliver efficient and effective program management of all GPT clinical development results including project strategy, design and delivery of program/studies to time, on budget and with quality
Oversee clinical components of regulatory and related submissions, maintenance support for regulatory interactions and reports, and clinical contributions to inspection readiness.
Lead all clinical operations activities within the program and for ensuring provision of clinical operations expertise/input into the program (e.g. feasibility, country selection, operational input into design, Risk based Quality Management and external partner management)
Act as the initial and program-level AZ operational interface with externally managed/outsourced partners (e.g. CRO/ARO) and collaboration/alliance partners for program planning and delivery
Bachelor of Science or equivalent degree.
~12+ years eExtensive experience across the product life cycle with experience in late stage development of Oncology assets.
~ Validated ability to develop programs to meet business goals and to assess business risk versus potential value.
~ Significant experience of program management and use of project management techniques in complex project including resourcing, financial management and business case development.
~ Willingness to travel both domestic and international.
Regulatory submission experience
Previous success of working in Japan and China to ensure delivery of global programs to meet business needs
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.
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