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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 Evidence 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, externally sponsored research and early access programs required by Global Product Teams and Global Medical Teams.
The Evidence Delivery Associate Director (EDAD) will be responsible for the governance, operational planning, budget management and oversight externally sponsored studies and/or early access programs/ compassionate use requests.
In addition, the EDAD will support BPM Evidence’s continuous improvement by developing expertise in a specific area of evidence delivery, serving as a point of contact for best practice, and contributing to the development and maintenance of guidance documents and training materials.
The EDAD will focus on one or two main types of work as described below.
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.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
Early Access (EA):
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
Lead the operational governance of the EAP vendor and provide active input into strategic vendor discussions, contracting and partnership to ensure effective collaboration and compliance
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
