Typical Accountabilities:
• Reviews literature and consults with internal experts to identify biological mechanisms underlying pathophysiology and/or potential drug effects

• Assists in the design and execution of studies to assess biological mechanisms such as preparing pharmacogenetics components of clinical study protocols

• Liaises with colleagues in Clinical Pharmacology to assist in the design and execution of Phase I Clinical trials to establish Proof of Principle and to support Proof of Concept

• Initiates and monitors epidemiological research done by external scientific groups and provides medical/physician expertise to epidemiology colleagues who are not physicians

• Acts as a regional technical expert supporting the delivery of strategic input within the area of Physicians and provides consultancy within area of specialism

• Responsible for the safety evaluation in the early clinical trials, as well as the pharmacodynamic evaluation of the early compounds

• Delivers pharmacogenetics contribution to Translational Science Plans and Clinical Development Plans

• Supervises volunteers participating in medical trials and reviews safety assessments

• Leads the development of setting statistical standards or techniques in order that the quality, efficiency or effectiveness of projects are improved for overall Group efficiency

• Accountable for specialised research to enhance the effectiveness of Biostatistics contributions to worldwide submissions across a range of products

• Provides highly experienced strategic input, statistical expertise, and leadership to project teams in the design and interpretation of clinical studies and programmes of studies

• Applies expert physician skills to support internal proposal development and external regulatory submissions

• Acts as a source of knowledge in area of expertise, defining and communicating important initiatives across departments and functions

• Contributes to establishing and implementing policies, procedures and objectives for own work or team area to ensure compliance with both internal and external regulations

• Provides professional expertise to optimally design, analyse and interpret epidemiological studies and perform in depth epidemiological literature reviews

• Responsible for the safety evaluation in early clinical trials, as well as the proper pharmacodynamic evaluation of the early compounds

• Promotes good physician practice and ensures adherence with relevant protocols

• Develops operational systems and research processes across area of responsibility to increase the effectiveness and efficiency of projects


Typical People Management Responsibility (direct / indirect reports):
• Approximate number of people managed in total (all levels) - 10
• Matrix Manager – (projects/dotted line)

What is the global remit? (how many countries will the role operate in?):
• Own country

Education, Qualifications, Skills and Experience:
• Essential: Bacherlor’s degree in medicine; Thorough knowledge of study analysis and design in all phases of drug development; Experience of modelling and simulation to improve execution of studies
• Desirable: Extensive general medical knowledge

Key Relationship to reach solutions:
• Internal (to AZ or team): Members of all functions on project team; Members of Development
• External (to AZ): External service providers; External regulatory agencies