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Senior Principal Scientist, Pharmacometrics Leader
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- Senior Principal Scientist, Pharmacometrics Leader
- The Senior Principal Scientist CPP Leader is responsible and accountable for developing compound specific Clinical Pharmacology strategy for the development of a compound, including interactions with regulatory agencies and functions as CPP Leader on the Compound Development Teams (CDT) working in collaboration with various stakeholders within the team and within Quantitative Sciences (e.g., Statistics, Pharmacometrics).
- The Senior Principal Scientist CPP Leader can independently execute the day to day operations for the clinical pharmacology aspects of the assigned programs and may provide management directly or indirectly to junior CPP leaders.
- Devise model informed drug development strategy via application of quantitative methods to integrate knowledge of PK, PD (e.g., biomarker, efficacy, and/or safety), patient characteristics, disease states, competitive and landscape to influence go/no go decisions, support patient sub-population, dose and dosage regimen selection, and optimize study designs throughout drug development.
- Represent CPP in relevant external regulatory meetings (e.g., End of Phase 2, pre-NDA / MAA, Advisory Committee meetings).
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