AstraZeneca’s (AZ) vision in Oncology is to help patients by redefining the cancer-treatment paradigm, with the aim of bringing six new cancer medicines to patients between 2013 and 2020. A broad pipeline of next-generation 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 five key platforms - immunotherapy, the genetic drivers of cancer and resistance, DNA damage repair, HER2 and antibody drug conjugates, underpinned by personalized healthcare and biomarker technologies.

Oncology Medical Affairs ensures the best patient outcomes by providing healthcare decision-makers around the world with the evidence and confidence they need on AZ therapies and supports our internal stakeholders with medical insight and expertise. The department provides medical leadership with market participation and connectivity while also impacting the life cycle planning and execution of all our products. Oncology Medical Affairs aims to lead AstraZeneca in achieving scientific leadership, being a great place to work, and keeping patients at the core of everything we do.

The Oncology Medical Evidence Delivery function is accountable for the operational delivery of global oncology studies that generate evidence to build the confidence on our AZ therapies. This evidence is generated from company sponsored observational and interventional studies required by Global Product Teams and Global Medical Teams. In addition the function oversees externally sponsored research and early access activities for our oncology products.

This Evidence Delivery Manager (EDM) role will either lead or support an Evidence Delivery Associate Director (EDAD) in the leadership of one or more cross-functional study teams responsible for the operational planning, delivery and reporting of AZ sponsored studies. These evidence generating multi-national studies are fully outsourced to External Service Providers (ESPs) and will either be prospective observational or interventional in nature.  In addition to various project managerial responsibilities, the EDM may take on the study team leader role in some cases and may help coordinate the efforts of extended team members within AZ, notably the scientific study leader (the Epidemiologist for observational studies, Medical Affairs Leader for interventional studies). The Evidence Delivery Manager role also supports continuous improvement activities which may involve developing expertise in a specific area of study delivery, serving as a point of contact for best practice, and contributing to the development and maintenance of guidance documents and training materials. Opportunities may also emerge to oversee externally sponsored research programmes and various early access activities.

Specific activities/responsibilities of this role in delivering company sponsored observational and interventional studies:

• Lead, or support an Evidence Delivery Associate Director (EDAD) in the leadership of a cross-functional team responsible for the delivery of one or more AZ sponsored prospective observational or interventional studies to agreed timelines, within the approved budget and according to AstraZeneca quality standards, using a full service outsourcing model.
• Support the selection of External Service Providers (ESPs) and the oversight of their activities throughout operational study start up, implementation and closure, ensuring inspection-readiness at all times and delivery per contract/associated KPIs
• Collaborate with ESPs and AZ team members to ensure the study operational activities are effectively undertaken and that roles and responsibilities are clearly understood
• Ensure compliance with AZ Procedural Documents, Standards and Policies, international guidelines and local regulations at all time and report compliance breaches where necessary
• Support accurate forecasting of timelines and costs; Undertake feasibility assessments with internal and external stakeholders
• Maintain accurate information regarding study progress and scope in business systems and support business reporting activities as necessary
• Support/coordinate AstraZeneca's input into the development and finalization of study related documents (e.g. protocol)
• Lead or support the management of stakeholders throughout study planning, delivery and reporting ensuring an effective communication approach and clarity of responsibilities between the AZ staff and ESPs
• Support effective collaboration with scientific/medical colleagues, the Epidemiologist/Medical Affairs Leader (MAL) respectively, as well as other cross functional team members
• Support (or lead) all activities needed to follow AstraZeneca's internal governance processes
• Ensure appropriate tracking, reporting, escalation and resolution of study risks and issues
• Support (or lead) financial management activities throughout the course of each study, including contract negotiation, cost forecasting & control, purchase order generation, invoicing, change order management, reporting; Support financial audit readiness and Sox attestation as needed

Required Experience

• Bachelor’s degree required preferably in medical or biological science or equivalent by experience.
• Excellent knowledge of the Clinical Study Process, international ICH/GCP guidelines
• At least 2 years experience project managing multi-national, multi-centre studies
• At least 1 years experience in the Oncology therapy area, preferably in a study management role
• Managed studies in the Phase III/Phase IV environment, ideally with experience in Real World Evidence studies.
• Broad knowledge around drug development generally and study delivery specifically

Core Skills

• Excellent communication skills
• Project Management qualification or demonstration of project management skills including scope, budget, timeline, resource management and use of associated tools.
• Financial management
• Collaboration/stakeholder management
• Ability to organize and prioritize for themselves and team
• Ability to lead core and extended cross-functional teams to deliver shared goals
• Ability to identify, develop and champion more efficient and effective ways of working
• External service provider management; holding partners accountable for their contracted deliverable

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe. As an Evidence Delivery Manager in Oncology, you will play a pivotal role in channelling our scientific capabilities to make a positive impact on changing practice and patients’ lives.

Next step - Apply today!

Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.