Director Quantitative Pharmacology

Organization
CSL Behring
Job Location
King of Prussia, PA
Job Description

The position of Director, Quantitative Pharmacology is a technically-driven, high-impact role in Clinical Pharmacology & Early Development (CPED; CMO function), which provides the incumbent an unique opportunity to advance and lead the field of pharmacometrics across the global R&D organization. The appointee will lead pharmacometrics science within R&D, at a portfolio level, spanning the pre-clinical stages through all clinical stages at CSL, working closely with CPEDs Directors of Clinical Pharmacology in identifying pharmacometric opportunities and strategy across portfolio to maximize value. The industry-experienced person undertaking this role will have a strong and proven pharmacokinetic/pharmacometrics knowledge, with demonstrable advanced modelling and simulation skills and pharmacostatistical knowledge. Close collaboration with various non-clinical, Research, Clinical R&D, and Commercial Development/Medical Affairs functions will be crucial, as well as strong interaction with world-leading pharmacometric (quantitative pharmacology) experts. The appointee will be required to ensure provision of pharmacometrics support to all R&D projects through the use of internal resources and external alliances, though undertaking hands-on modelling and simulation work on selected crucial projects will also be a requirement.
The position of Director, Quantitative Pharmacology is a technically-driven, high-impact role in Clinical Pharmacology & Early Development (CPED; CMO function), which provides the incumbent an unique opportunity to advance and lead the field of pharmacometrics across the global R&D organization. The appointee will lead pharmacometrics science within R&D, at a portfolio level, spanning the pre-clinical stages through all clinical stages at CSL, working closely with CPEDs Directors of Clinical Pharmacology in identifying pharmacometric opportunities and strategy across portfolio to maximize value . The industry-experienced person undertaking this role will have a strong and proven pharmacokinetic/pharmacometrics knowledge, with demonstrable advanced modelling and simulation skills and pharmacostatistical knowledge. Close collaboration with various non-clinical, Research, Clinical R&D, and Commercial Development/Medical Affairs functions will be crucial, as well as strong interaction with world-leading pharmacometric (quantitative pharmacology) experts . The appointee will be required to ensure provision of pharmacometrics support to all R&D projects through the use of internal resources and external alliances, though undertaking hands-on modelling and simulation work on selected crucial projects will also be a requirement. 



Requirements: 

Position Qualifications and Experience Requirements 
Education 
Doctoral degree with demonstrated expertise in pharmacometrics and strong quantitative skills (e.g. proven experience in most of the following areas: population and PK/PD modelling, mechanistic modelling, systems biology, species scaling methodologies and derivation of first-in-human doses, disease modelling and meta-analyses).
Experience 

•A minimum of 8 years of pharmaceutical industry (or relevant) experience, specifically contributing to pharmacometrics aspects of clinical drug development.
•In-depth knowledge and experience in advanced PK and PK/PD
•Advanced pharmacometric knowledge in one of the following core sub-specialty: Systems Pharmacology, advanced Exposure-Response Models, Disease Models, Physiological-Based Pharmacokinetic Models
•Working knowledge and experience of software such as NONMEM, SAS, S-Plus, R, WinNonlin, and other server-based data processing and modelling tools
•Knowledge of the role of pharmacometrics in drug development and FDA/ICH requirements for drug registration
•Knowledge and application of statistics, random effects modelling, mixed effects modelling, data mining, population PK/PD analyses and modelling (including nonlinear models), Bayesian methods, clinical utility indices, and Monte-Carlo simulation
•Clinical trial design and simulation
• PK and PD drug interactions, in vivo/in vitro models 
• Ability to understand, lead and implement all aspects of pharmacometrics needs across a variety of disease areas 
Regulatory and Quality Systems 

•Representation and pharmacometrics leadership at regulatory authority meetings
•IND, CTA submissions
•ICH Good Clinical Practice and Good Laboratory Practice
•EMA and FDA guidelines
•Quality Control systems and processes for data analytical work to meet Regulatory requirements
•In-depth knowledge of, and experience with global clinical pharmacology and pharmacometrics regulatory requirements 
Worker Type:
Employee
Worker Sub Type:
Executive

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