Sr Clinical Pharmacologist, Clinical Pharmacology and Pharmacometrics

The Sr Clinical Pharmacologist / Associate Director, Clinical Pharmacology and Pharmacometrics serves as the clinical pharmacology lead on program, clinical and study teams, providing strategic leadership and execution of clinical pharmacology plans for drug candidates. He/she will integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to optimize doses, dosage regimens and study designs throughout clinical drug development.

? Responsible for drafting and executing clinical pharmacology development plans and providing clinical pharmacology expertise to program and clinical teams ? Leads clinical pharmacology study efforts (e.g. study design, protocol preparation, clinical phase oversight and reporting). Analyzes and interprets results and recommends action based on study results. ? Directs planning of all relevant PK-PD analyses; performs or guides such analyses as appropriate. Works to ensure population PK, PK-PD modeling and simulation, meta-analysis, etc are integrated into the development plan ? Responsible for appropriately summarizing, modeling and interpreting results of pharmacokinetic/pharmacodynamics analyses with respect to their impact on development and clinical use of drugs. ? Supports regulatory strategy for filings and is responsible for clinical pharmacology sections of regulatory documents. Contributes or leads the resolution of clinical pharmacology queries from regulatory agencies, takes a lead role in writing and reviewing responses to regulatory queries. ? Maintain current knowledge of literature, government guidelines, internal guidance in order to be a team resource of clinical pharmacology knowledge in terms of both therapeutic area background and clinical trial design

• 5+ years relevant industry experience (clinical pharmacology and/or clinical PK/PD)
• Demonstrates an understanding of 1) PK/PD principles, physiology, pharmacology and pathology; 2) operational and scientific aspects of early development studies; and

Sr Clinical Pharmacologist, Clinical Pharmacology and Pharmacometrics