AstraZeneca Pharmaceuticals LP Associate Director of Clinical Development - Oncology in Cambridge, United Kingdom
At AstraZeneca, we’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. We want to redefine the cancer-treatment paradigm, and we aim to bring six new cancer medicines to patients by 2020.
Join us as an Associate Director of Clinical Operations in Global Medicines Development (GMD), where you can be a part of turning exciting science and innovative molecules into medicines that change lives. Our broad pipeline of next-generation oncology medicines is focused principally on four disease areas – breast, ovarian, lung and haematological cancers. As well as other tumour types, these are being targeted through four key platforms: immunotherapy; the genetic drivers of cancer and resistance; DNA damage repair; and antibody drug conjugates.
By driving the late stage development of our pipeline, we enable the business to make critical pipeline and investment decisions. In this role, you will be responsible for leading the project planning and operational delivery of clinical work packages. The span of activities is broad covering clinical activities in late drug development, registration/submission and post registration product maintenance phases and will include local and global working.
You will lead and manage defined clinical deliverables across a broad range of activities. This can include the responsibility to lead complex components of a clinical program such as Life Cycle Management, clinical submission activities, or indication development responsibilities or lead independent work packages or maintenance projects. Tasks involve project planning and operational delivery of clinical programmes, and project management of the scope, schedule and budget.
Lead a cross functional team of clinical experts in the planning and delivery of a defined clinical project to scope, quality, budget, time, managing resource and risk (e.g. large studies/package of studies, clinical submission teams , regulatory defense, inspection readiness, payer evidence)
Provide clinical operations expertise into the project (e.g. country selection, feasibility, operational input into design, external partner management) to support governance interactions and project start-up Responsible for project management including the development, baselining and maintenance of realistic, up to date and appropriate quality, project and study plans (including timings and total costs) in agreed systems (such as IMPACT, OPAL and ACCORD)
Identify and resolve issues within the clinical project including the escalation of the issue to the appropriate individual/functional/governance group for resolution
Lead a large/complex work package (i.e. indication) and the process to identify and solve operational issues and drive delivery to plan through internal or external partners (Alliance partners, CROs, vendors and Academic Research Organizations).
Act as AZ project interface with external (e.g. CRO/ARO) partners for externally managed/outsourced studies as appropriate
Be responsible for ensuring timely compliance with companywide governance controls (e.g. Sarbanes-Oxley, ACCORD access and study attestations, continuous assurance, Letter of Assurance and Clinical Trial Disclosure)
May be assigned responsibility for leadership and program/project management of non-drug project work
University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred
Considerable experience of clinical research and/or oncology drug development gained in an academic, pharmaceutical or CRO environment
Extensive knowledge of clinical operations, project management tools and processes
Proven experience of clinical development / drug development process in various phases of development and therapy areas
Experience of leading clinical projects and deliverables or similar expertise from other areas of drug development (such as pharmaceutical development)
Project management certification
Knowledge of process improvement methodology such as Lean Sigma/Change Management
Experience within the field of Immuno oncology
If you are interested, please apply now!
Closing date for applications is 31st May 2018.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership.