AstraZeneca is at a critical phase in the journey to deliver on our bold ambition; to improve the lives of 200 million patients and be a $50 billion company in 2025. We are on track to deliver 10 new medicines by 2020. Within the Oncology/Immuno-oncology Therapeutic Area our vision is to transform the lives of patients and one day eliminate cancer as a cause of death. We aim to do this by:
- Creating a diverse portfolio of small and large molecules.
- Maximising the value of our portfolio, across tumour types and stages of disease through smart development.
- And by unlocking the power of combinations in immuno-oncology with both biologics and small molecules.
Global Clinical Operations will make the company vision a reality, through the delivery of global clinical trials for late-stage projects recruiting many thousands of patients every year in countries across the world. Our operating model requires excellence in cross-functional collaboration within our dedicated Oncology internal delivery model and through our partnerships with Clinical Research Organisations and independent collaborative/cooperative groups.
A vacancy has now arisen for an experienced Associate Director to join our current team. As Associate Director you will be responsible for leading the project planning and operational delivery of clinical work packages in Clinical Operations, GMD. 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.About the Role
The Associate Director - Clinical Development role is to 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. In addition to clinical work in drug projects, the ADCD may manage improvement or change projects in other business areas. The ADCD may be aligned to one or more projects depending on size and complexity and is responsible to the Director Clinical Development for the program.Key responsibilities
- Leading 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, submission planning, regulatory defense, inspection readiness, payer evidence)
- 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)
- Provide input into study feasibility, study specifications, vendor/partner contracts and essential documents such as clinical study protocols
- Lead a large/complex work package or manage a clinical study 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 operational interface with external (e.g. CRO/ARO) partners for externally managed/outsourced studies as appropriate
- 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.
- Significant experience from within the pharmaceutical industry or similar large multinational organization.
- 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.
- Proven ability to learn by working in multiple phases, TAs and/or different development situations.
- Experience from 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
Opening date: 30th November 2017
Closing date: 30th January 2018 Next Steps - Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience. If you know someone who would be a great fit, please share this posting with them.
AstraZeneca is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, or protected veteran status and will not be discriminated against on the basis of disability.