Medical Evidence Delivery Operations within the Oncology Business Unit (OBU) is responsible for the operational delivery of observational and interventional AstraZeneca sponsored studies, externally sponsored research and early access programs in order to generate the evidence to build confidence in AZ therapies and provide access to AstraZeneca therapies for patients in need.

Evidence Delivery Associate Director (EDAD) will be responsible and accountable for the operational planning, delivery, oversight and budget management of either Company Sponsored studies, Externally Sponsored Research studies, or Early Access Programs. The EDAD may lead a matrix team of manager/specialists/associates to support the delivery of activity in their assigned area. The EDAD may lead the oversight and relationship management for any external partners/ vendors utilised.

Role Responsibilities:

Usually, the EDAD’s focus will be on one of the three main types of work as described below.

Specific activities/responsibilities per type of study:

1) Company Sponsored Observational and Interventional Research:

Input into Study Design Concept (SDC):

• Responsible to provide the insights on operational feasibility during the SDC development process.

Accountable for protocol:

• Drive the process of coordinating protocol development by ensuring input of all relevant cross functional (internal) and external stakeholders
• Responsible to provide input on operational feasibility of the protocol.

Manage Study Governance (post SDC):

• Coordinate all internal, study governance processes
• External Service Provider Management
• Lead the process for selection of External Service Providers (ESPs), including Clinical Research Organisations (CROs)
• Collaborate with CRO/ESP to ensure the study operational aspects are effectively undertaken and ensure that study delivery is within time, cost and quality limits
• Manage study specific issues and escalations with ESPs/CROs.

Stakeholder Management:

• Effective collaboration with the scientific/medical counterpart, the Epidemiologist/Medical Affairs Leader (MAL) respectively, as well as other internal cross functional global roles
• Report study updates from a time, cost and quality perspective to internal stakeholders
• Clarify and document an effective communication approach, as well as roles and responsibilities between the OBU stakeholders, local AZ and External Service Providers.
• Ensure appropriate level of involvement of the external scientific community (e.g. (Inter)national Coordinating Investigators, Steering/Executive Committee) during study design and delivery.

Manage study finance:

• Develop and maintain the overall study budget (internal and external study costs)
• Keep transparency on study budget and changes through relevant systems and platforms (Planning Performance and Control (PPC) meetings) and obtain approval for budget changes
• Work with procurement on study agreement and manage subsequent out of scope changes for ESP/CRO
• Manage and reconcile Contracts, POs and invoices
• Financial audit readiness and Sox attestation.

Other Project Management activities:

• Deliver studies to agreed timelines (scorecard), within the approved budget and according to AstraZeneca quality standards
• Ensure global oversight over the operational study start up, implementation and closure and ensure inspection readiness
• Lead study related change management within business strategy
• Ensure Compliance with AZ Procedural Documents, Standards and Policies, international guidelines and local regulations at any time, and report compliance breaches
• Undertake feasibility assessments with internal and external stakeholders
• Manage study system reporting
• Lead the study and manage the study team stakeholders (e.g. core team, extended team, delivery team).

2) Externally Sponsored Scientific Research (ESR):

Governance:

• Ensure operational compliance with policies and procedures for ESRs globally.

Delivery:

• Manage across a range of global and local cross-functional stakeholders to ensure all AZ obligations and responsibilities for ESR (e.g. drug supply, contracting, regulatory documentation, publication review etc.) are met
• Manage external stakeholder, e.g. external Investigator and Sponsoring institutions
• Lead ESR portfolio financial forecasting and budgeting for assigned ESR studies/portfolios, utilising appropriate Company systems to facilitate awareness and understanding of ESR budget commitments (e.g. forecast versus actuals)
• Provide oversight to local Marketing Companies (MC’s) to ensure all operational delivery aspects of ESR are achieved within agreed timelines and budgets, to expected levels of quality, and in line with the legal and compliance requirements, escalating issues around non-attainment of performance metrics as appropriate
• Lead and manage the delivery of complex multi-product/country/cross regional collaborative ESR studies. Co-ordinates complex ESR in conjunction with MCs, overseeing Medical Affairs specialists and/or study management specialists to ensure compliance with project management guidelines, external regulations and internal processes/policies to enable high quality research
• Acts as the first point of contact for local MC operational enquiries
• Tracks all ESR study time, cost and quality KPIs, taking corrective action as required. In doing so, guides the MC in the changing of ESR study milestones and finances in light of changing needs and requirements to ensure that deliverables continue to be efficiently and effectively met.

3) Early Access (EA) /Named Patient Supplies (NPS):

• Lead the planning, implementation and delivery of EA programmes
• Collaborate with vendors to ensure the EA Program operational aspects are effectively undertaken and that they have clear remits for delivery to ensure EA Program is on time, on budget and of high quality
• Manage the resolution of program specific issues and escalations with internal (e.g. Global Clinical Leads, Chief Medical Office, supply chain representatives) and external stakeholders
• Manage the review process of NPS requests to ensure timelines for decision making are adhered to, utilising appropriate Company systems, so that a decision on the request can be returned to the patient’s physician.

Education, Qualifications and Experience:

• Bachelor’s degree required preferably in medical or biological science or equivalent by experience.
• Master’s degree in a scientific discipline is desirable.
• Extensive pharmaceutical industry/CRO experience within clinical study/research project delivery, drug development process and relevant guidelines, for example GCP/ICH.
• Project Management qualification or demonstration of project management skills including scope, budget, timeline, resource management and use of associated tools.
• Ability to effectively work with Clinical Research Organisations/External Providers/Academic Institutions.
• Proven ability to interact widely and effectively internal and external to the company across geographic regions, functions and cultures.
• Experience and knowledge within compliant management of Externally Sponsored Scientific Research.
• Persuasive communicator in English with a proven ability to work collaboratively in a multi-cultural environment.
• Open to occasional travel.

Please note the role can be considered at career levels E (Evidence Delivery Manager) or F (Evidence Delivery Associate Director) depending on the suitability and experience of the successful candidate.

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.