Opportunities in modeling & simulation at AstraZeneca

*Senior Pharmacometrician* * * *To apply*: http://jobs.astrazeneca.com/jobs/details/l1rRD777-senior-pharmacometrician · *Reference Number: *RD777 · *Date Added*05/10/2013 · *Country **United http://jobs.astrazeneca.com/jobs/country/united-kingdom · *Location* http://jobs.astrazeneca.com/jobs/location/cambridge · *Career Area* http://jobs.astrazeneca.com/jobs/category/clinical This is a scientific job with responsibility for the population PK, PKPD, exposure-response, disease modelling in all clinical phases of Clinical Development. The incumbent will be responsible for integrating emerging clinical data with existing preclinical models and literature data and developing mathematical/statistical models that will be used in model based drug development (MBDD). · Accountable for expert data analysis, interpretation, and reporting of results · Input into pre-clinical, clinical, and post-approval development plans · Use of a variety of innovative quantitative methods to integrate data of pharmacokinetics, biomarkers, and clinical outcome (desirable and undesirable effects) with data of patient characteristics and knowledge of disease mechanisms and disease states to facilitate quantitative decision making · Translate pre-clinical into clinical models, using emerging clinical data, to establish a model continuum · Development of mechanistic disease models and dose-exposure-response models · Use of M&S to influence study design and decisions · Internal and regulatory submission documents related to M&S · Compliance with Good Clinical Practice (GCP) regulations and guidances of regulatory authorities Other responsibilities · Evaluating of new data analysis techniques and software and integration into standard working practices · Presentation and communication of results internally and externally at scientific meetings and in front of regulatory authorities, particularly regarding the End of Phase IIb meeting · Organisation of educational activities for the PM discipline · Driving AZ's ambition to become a leader in the use of quantitative approaches in drug development leading to the worldwide registration of new medicines · Evaluation of candidates for in-licensing · Participation in and accountability for peer review of reports and presentations · Supervision of modelling work performed by external contractors and more junior pharmacometricians Essential · Significant demonstrated expertise within the field of modeling and simulation · Knowledge about contemporary software and tools within the field of M&S · Strong leadership capabilities, in particular with regards to influencing skills · Early and late stage drug development experience · Bachelor degree required with advanced degree preferred · Demonstrated broad clinical development expertise and experience exemplified by significant international Drug Development Experience, with emphasis on Pharmacometrics · A demonstrated knowledge of regulatory, compliance, processes ,standards and issues specific to pharmacometrics · Credibility with academic partners, partners in cross-company initiatives, CROs, Public Private Partnership consortia A clear demonstration of behaviours of · Truth seeking rather than success seeking · Agile responsiveness to scientific data · Embracing of peer review · Agnostic to internal-external sourcing Desirable · International scientific reputation gained from scientific publishing in the field on pharmacometrics · Early and late phase clinical development experience/awareness · Experience in several organisations *Salary:* Competitive *Closing Date:* 7th November 2013