Clinical Pharm Lead (FSP)
求人ID R0000034006 Category Medical SciencesAbout this Role
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 design 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, pathophysiology and 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.
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