BioPharma Medical Evidence Associate Director ESR

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.

The BioPharmaceuticals Medical Global Evidence Portfolio 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.

About the role:

Evidence Delivery Associate Director (EDAD) within Externally Sponsored Research team is responsible for the operational delivery of assigned interventional and observational ESR studies to budget, quality and timelines. The EDAD acts as the primary operational contact for external Investigator and Sponsoring institutions. The role is responsible for coordinating ESR operational processes for cross functional team members for assigned studies to ensure adherence to timelines of ESR study execution. The EDAD monitors performance against contractual commitments and manages ESR management system to reflect most accurate and up to date study information through the whole life cycle.

The EDAD is supporting and providing oversight and direction on ESR operational processes and conducts performance assessment on assigned portfolio during the ESR study life cycle to ensure quality delivery.

Externally Sponsored Scientific Research (ESR):

• Acts as primary operational contact for US external Investigator and Sponsoring institutions

• Provides guidance and training on ESR operational processes for internal and external stakeholders as needed  and manages compliance with US policies as well as global policies and procedures

• Supports the review of US ESR proposals and protocols to enable a consistent, high quality approach to evaluation 

• 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

•  Monitors performance of external sponsor and the study progress, holding Sponsor accountable to contractual obligations and completeness of all essential documentation

• Support 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 aspects of the delivery of complex multi-product/country/cross regional collaborative ESR studies. Co-ordinates complex ESR in conjunction with MCs, collaborating withoverseeing Medical Affairs colleaguesspecialists 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

• Effective relationship building and stakeholder management skills

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 authorisation and employment eligibility verification requirements.