Reference: PW 6467
Closing Date: 24 Nov 16
Salary (£): Competitive
· Global Pharma company
· Hertfordshire based
•Support global head of Modelling & Simulation (M&S) in acting as a mentor and coach to team members
•Support global head of M&S to manage/oversee outsourced work with collaborating CROs for M&S work.
•Support global head on M&S in providing expert support to others within Global Clinical Pharmacology/Translational Medicine and project teams with respect to the design and analyses of population PK (/PD) studies.
•Contribute to the development of appropriate internal procedures to manage M&S work and oversee SOPs/SWPs related to population M&S.
•Generating, compiling and oversee M&S analysis plans and reports in accordance with departmental SOPs/SWPs and regulatory guidelines.
•Conducting PK and PK/PD data analysis, using both non-compartmental and population approaches.
•Interact actively with clinical, statistics and data management functions
•Draft and/or review Investigator Brochures, IMPDs, relevant sections of submissions documents (CTDs) and other Regulatory documents.
•Prepare Population PK and PK/PD related responses to requesting regulatory agencies.
•Represent company at major scientific and medical meetings.
•Keep up to date on best current practices and knowledge in the fields of M&S and population PK/PD by attending training courses, conferences and reading relevant literature
QUALIFICATIONS / EXPERIENCE REQUIRED:
Qualified to a master or preferably to PhD degree in the field of PK and PK/PD modelling.
Experience in the area of pharmacometrics is a must with preferable experience in the clinical development of oncology drugs.
The use of the software NONMEM is essential for the job. Experience in using R, S-plus and/or SAS will be an advantage.
Strong inter-personal skills are required since the job requires a lot of interaction within the M&S team as well with other supporting and clinical functions.
Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.
For a confidential discussion please telephone Andrea Litovszky at AXESS Limited on 020 8560 2300. To apply, please send your CV to firstname.lastname@example.org quoting reference PW 6467
PK/PD, Pharmacokinetics, pharmacodynamics, NONMEM, DMPK, PK Scientist, Pharmacokineticist, PK Modelling, PK simulations, PD Modelling, Modelling and Simulation, PKPD, S-plus, SAS, Modelling, modeling, pharmacology, pharmacometrics. PD Scientist, Senior Manager, Associate Director, Clinical Phamacology, Translational Medicine.
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