Clinical Pharmacology Lead providing expertise to multidisciplinary project teams for oncology programs. Responsible for clinical pharmacology studies and regulatory contributions.
Responsibilities
Represent Clinical Pharmacology on Clinical Sub Team and Development Team
Participate in the implementation of model-based drug development
Provide clinical pharmacology components of Clinical Plans
Serve as an expert on the clinical pharmacology profile of allocated drugs
Coordinate with Medical Writers in the data review, analysis and reporting of the CP study
Responsible and accountable for non-compartmental analysis of PK data
Use innovative analytical methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states
Provide recommendations for clinical doses and dosing algorithms
Leads clinical pharmacology contributions to all regulatory documents
Provide Clinical Pharmacology expertise to Discovery during the pre-clinical stages of drug development
Requirements
PhD or PharmD
3+ years of related experience
Experience applying pharmacokinetic and pharmacokinetic-pharmacynamic concepts, including modeling and simulation to clinical trial design
Clinical drug development experience in oncology or other therapeutic area
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