Evidence Delivery Associate Director (EDAD)
Business Area:
BioPharmaceuticals Medical (BPM) ensures the best patient outcomes by providing healthcare decision-makers around the world with the evidence and confidence they need on 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 AstraZeneca in achieving scientific leadership, being a great place to work, and keeping patients at the core of everything we do.
About the role:
Evidence Delivery Associate Directors(EDAD) will lead or support the operational planning, delivery, oversight and budget management of company and/or externally sponsored research. They may also help coordinate the efforts of extended team members, notably the scientific study leader (epidemiologist for observational studies, Medical Affairs Leader for interventional studies).The EDADmay own specific areas or deliverables within a study, or in some cases, assume the accountabilities of a team leader for study delivery.
In addition, the EDADwill 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 EDAD’s focus will be on one of the three main types of work as described below.
Roles & Responsibilities:
Company Sponsored Observational and Interventional Research:
Company sponsored observational and interventional research
Support/coordinate protocol development and finalization
Manage Study Governance (post SDC)
Support/coordinate all internal, study governance processes (e.g. ERT, MARC, LSPC, ClinicalChallenge)
External Service Provider Management
Provide input into theselection of External Service Providers (ESPs), including Clinical Research Organisations (CROs)
Support strategic handover meetings and kick off meetings
Perform CRO oversight to help ensure project delivery within time, cost and quality
Collaborate with CRO/ESP to ensure the studyoperational aspects are effectively undertaken and that they have clear remits for delivery
Manage study specific issues and escalations with ESPs/CROs
Stakeholder Management
Support Project team set-up and study sourcing activities
Support effective collaboration with the scientific/medical counterpart, the Epidemiologist/Global Medical Affairs Leader (GMAL) respectively, as well as other internal cross functional global roles
Report study updates for areas of responsibility from a time, cost and quality perspective to internal stakeholders (e.g.Evidence Delivery Director(EDD))
Support implementation and upkeep of an effective communication approach, as well as roles and responsibilitiesbetween the BPM Evidence stakeholders, local AZand External Service Providers
Coordinate efforts/input of the external scientific community (e.g. (Inter)national Coordinating Investigators, Steering/Executive Committee) during project design and delivery
Manage study finance:
If leading a study, develop and maintain the overall study budget (internal and external study costs)
Ensure transparency overareas of budget responsibilityby updating through relevant systems (s.a. ACCORD) and platforms (PPC meetings) and obtaining approval for budget changes
Work with procurement on project agreement and manage subsequent out of scope changes for ESP/CRO
Manage and reconcile Contracts, POs and invoices
Support financial audit readiness and Sox attestation as needed
Other Project Management activitiesas applicable
Support delivery of projectsto agreed timelines (scorecard), within the approved budget and according to AstraZeneca quality standards
Support global oversight over the operational study start up, implementation and closure and ensure inspection-readiness
Support implementation of study-related change management within business strategy, s.a. 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 systems reporting
Externally Sponsored Scientific Research (ESR):
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
Support ESR portfolio financial forecasting and budgeting for assigned ESR studies/portfolios, utilising appropriate Company systems to facilitateawareness 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 aspects of 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 projects
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
Ensure operational quality and compliance with policies and procedures for ESRs globally
Early Access (EA) /Named Patient Supplies (NPS):
Leads aspects of the planning, implementation and delivery of EA programmes
Perform vendor oversight to ensure EA Program delivery to time, cost and quality
Collaborate with vendors to ensure the EA Program operational aspects are effectively undertaken and that they have clear remits for delivery
Manage triaging 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
Requirements:
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
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AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.
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.
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