Key Accountabilities:

General Accountabilities

·       Plans and directs clinical pharmacology components of clinical programs (including clinical development plan and medicine plan) and studies (including design, synopsis preparation and reporting). 

·       Works with multifunctional study team to design, deliver and report the assigned clinical pharmacology studies and has overall scientific accountability for the designated studies. 

·       Accountable for the development and implementation of a clinical modeling and simulation plan based on agreed-upon best practices (i.e. model-informed drug development). 

·       Responsible for use of quantitative methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to optimize doses, dosage regimens and study designs throughout clinical drug development. 

·       Responsible for appropriate summarization and interpretation of results of pharmacokinetic/pharmacodynamic (PK-PD) analyses with respect to their impact on development and clinical use of drugs

Compliance with Parexel standards 

·       Comply with required training curriculum.  

·       Complete timesheets accurately as required.  

·       Submit expense reports as required.  

·       Update CV as required. 

·       Maintain a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements.  

Skills:

·       Demonstrates thorough understanding of the following: 1) principles of PK, PK-PD and pharmacology relevant to drug candidates; 2) other relevant scientific disciplines, including drug metabolism, drug transport, formulation sciences, biopharmaceutics, pathophysiologyand therapeutics; and 3) quantitative modeling and simulation principles. 

Knowledge and Experience:  

·       Keen problem-solving skills. 

·       Fluent in both oral and written English. 

·       Fluent in host country language required.  

Education:

·       Pharm. D., Ph.D., or equivalent training or experience in pharmacokinetics, pharmacometrics, clinical pharmacology, engineering or related discipline.