*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