EVIDENCE DELIVERY DIRECTOR

BioPharmaceuticals Medical (BPM) ensures the best patient outcomes by providing healthcare decision-makers around the world with the evidence and confidence they need on AstraZeneca (AZ) therapies and support our internal stakeholders with medical insight and expertise.
BPM provides medical leadership with market participation and connectivity while also impacting the life cycle planning and execution of all our products.
BPM aims to lead AZ in achieving scientific leadership, being a great place to work, and keeping patients at the core of everything we do.
The BioPharmaceuticals Medical Global Evidence Portfol io Delivery organization is accountable for the operational delivery of global strategic studies required to generate the evidence to build the confidence on AZ therapies and additional observational, interventional and externally sponsored research required by Global Product Teams and Global Medical Teams.
The Evidence Delivery Director (EDD) will be responsible and accountable for the operational planning, delivery, oversight and budget management of company sponsored studies and/or externally sponsored studies and/or Early Access Programs.
The EDD will work hand in hand with the scientific study leader who is responsible for all scientific aspects throughout all stages of the study (epidemiologist for observational studies, Medical Affairs Leader for interventional studies).
In addition, the EDD will support BPM Evidence’s continuous improvement by 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.
Usually, the EDD’s focus will be on one of the three main types of work as described below.
Specific activities/responsibilities per type of study.
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 (e.
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ERT, MARC, LSPC, ClinicalChallenge)   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   Set up study team and manage study sourcing   Effective collaboration with the scientific/medical counterpart, the Epidemiologist/ Global Medical Affairs Leader (G 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 BPM Evidence stakeholders, local AZ and External Service Providers   Ensure appropriate level of involvement of the external scientific community (e.
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(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 (s.
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ACCORD) 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, s.
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assessment of scope changes.
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.
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core team, extended team, delivery team     Externally Sponsored Scientific Research (ESR).
Governance.
Responsible for leading the review and evaluation of all ESR proposals and protocols, in line with a product’s scientific strategy, within a Therapeutic Area (TA)   Ensure operational compliance with policies and procedures for ESRs globally   Responsible for implementation of ESR quality framework within a TA    Delivery.
Manage across a range of global and local cross-functional stakeholders to ensure all AZ obligations and responsibilities for ESR (e.
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drug supply, contracting, regulatory documentation, publication review etc.) are met   Manage external stakeholder, e.
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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.
.
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     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.
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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       Typical Accountabilities     Independent of the study type, key accountabilities in the remit of the Evidence Delivery Director are.
Management of study Governance processes   Management of cross-functional internal and external stakeholders   Finance Management   Overall Project Management to deliver according to cost, time and quality   Risk Management, Quality Management   Study compliance   Team Leadership and team resource management       Education, Qualifications and Experience     Essential   Bachelor’s degree required preferably in medical or biological science or equivalent by experience.
Extensive pharmaceutical industry/CRO experience within clinical study/research project delivery, drug development process and relevant guidelines, for example GCP/ICH, for a specific therapeutic and geographical area.
Project Management qualification or demonstration of project management skills including scope, budget, timeline, resource management and use of associated tools.
Scientific awareness and extensive knowledge of observational study guidelines and SOPs   Extensive knowledge of early and late stage Pharmaceutical Development    Ability to effectively work with Clinical Research Organisations/External Providers.
Proven ability to interact widely and effectively within the company across 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 periods of travel     Why AstraZeneca? AstraZeneca is a place where scientific knowledge meets business acumen.
We are at the forefront of healthcare innovation, shaping the future of Healthcare.
We provide medical leadership across the whole product lifecycle - from advising on Research & Development investment decisions, to leading pre-launch scientific efforts and accelerating evidence-based healthcare changes in the real world.
We are networkers and influencers by nature.
In our role as scientific ambassadors, we thrive on working with people internally and externally.
The patient is at the heart of everything we do.
Our teamwork sets us apart and keeps us leading the way.
Ready to make a difference? Apply today! 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.