cartermackay Associate Director, Clinical pharmacology –PA
- Lead, with a high degree of independence, the clinical pharmacology and PK-PD strategy for portfolio programs, working in conjunction with the Pharmacometrician, Clinical Program Director, Clinical scientists, Biostatisticians, and other CDT colleagues.
- Lead the design of clinical pharmacology studies or protocol sections as required throughout all stages of drug development and provide oversight for implementation of such studies together with Clinical Development, Clinical Safety and Clinical Research Operations.
- Plan and implement relevant PK-PD analyses, including non-compartmental analysis of PK data and relevant PK-PD analysis as required.
- Lead the high quality review and interpretation of clinical pharmacology study results and oversee the presentation and writing thereof in clinical study reports, publications and related study documentation.
- Independently provide clinical pharmacology & pharmacometrics representation on clinical development matrix teams, ensuring cross-functional alignment and integration of the clinical pharmacology strategy within the global development plan.
- Independently implement the use of innovative analytical methods such as pharmacometrics/modeling & simulation to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states in support of optimal study designs, throughout an assigned clinical development program.
- Provide effective clinical pharmacology contributions to protocols, regulatory documents including Investigator Brochures, Submissions, Labeling and those required for face to face attendance at regulatory meetings and regulatory filings. Provides resolution of clinical pharmacology queries from regulatory agencies, taking a lead role in setting strategy to and writing responses.
- Required: PhD with 6+ years in clinical pharmacology/pharmacokinetics
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