Director, Clinical Operations - Late Oncology
Do you have expertise in and a passion for global Clinical Program Management? Would you like to apply your expertise to impact the development of late oncology clinical development in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.
Late Stage Oncology is the science engine room for our late stage development. Our strategy and ability to transform our portfolio means we have a late stage pipeline that presents opportunities to push the boundaries of science to deliver medicines. We transform clinical concepts into medicines that deliver patient health benefits!
The Director of Clinical Development (DCD) is a core global role within the Clinical Operations function of Late Stage R&D (BioPharmaceuticals and Oncology), focusing on operational strategy and delivery. The span of the responsibilities is broad and may support one or several products depending on their size and complexity. The products supported will be Phase 3 development or on the Market, but the program may include studies in all phases of drug development.
What you’ll do
The Director of Clinical Development (DCD) sits within Clinical Operations of Late Stage Oncology R&D and is accountable for leading the Clinical Program Team (CPT), a strategic and operational leadership team. You will be responsible for program leadership of all Late Stage clinical development deliverables (scope, quality, budget, time, resource and risk). The role involves integrating strategy, design, feasibility and operational planning to produce business-focused clinical drug development programs that align with AstraZeneca priorities and strategy. The DCD brings product knowledge and strategic thinking to support governance interactions, lead the delivery of a program of studies and co-ordinate the delivery of the clinical components of Health Authority submissions and documents. You will:
• Effectively partner with the Global Clinical Leader and Global Project Statistician to provide clear direction and aligned goals
• Drive and implement critical initiatives on the program level ensuring the CPT is operating as a high functioning team
• Deliver efficient and effective program management of all GPT clinical development deliverables 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
Essential for the role
Bachelor of Science or equivalent degree
Extensive global drug development leadership or equivalent leadership experience demonstrated in a variety of roles.
Extensive experience across the product life cycle with experience in late stage development.
Comprehensive knowledge of clinical operations and the clinical and pharmaceutical drug development process.
Proven 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.
Desirable for the role
Master of Science / Advanced degree preferred
Demonstrated ability to drive process improvement and/or functional work
Experience of implementing changes in ways of working that focus on increasing efficiency
Regulatory submission experience
Previous success of working in Japan and China to ensure delivery of global programmes to meet business needs
Proven experience in leading teams through change
Experience of and insight into the Clinical environment to be able to drive major improvement programs
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.
So, what’s next?
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you. Apply today!
Where can I find out more?
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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. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.