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- Associate Director, Clinical Pharmacology/DMPK Management Boston, MA, US
- Fusion is looking for an Associate Director, Clinical Pharmacology/ DMPK to join non-clinical development group.
- The successful candidate must have experience and foundational knowledge and experience in clinical pharmacology, drug metabolism, pharmacokinetics, bioanalytical and PK/PD M&S.
- Serve as lead clinical pharmacologist/ DMPK representative on cross-functional development teams and be able to influence project strategy.
- Lead the design, protocol development, execution, analysis, and reporting of clinical pharmacology/ DMPK studies.
- Contribute to regulatory submissions and health authority agency interactions relevant to clinical pharmacology/ DMPK including but not limited to pre-meeting briefing package, IND, IB, CTA and NDA.
- Manage external vendors to perform bioanalysis, in-vitro/in-vivo ADME/ toxicity studies in support of early clinical programs and regulatory submissions.
- Solid working knowledge of Pharmacokinetics, PK/PD principles applied to modeling, ADME and clinical pharmacology concept and understanding of regulatory guidelines on DMPK/ clinical pharmacology studies to support early oncology drug development.
Associate Director, Clinical Pharmacology - Boston, United States - Fusionpharma
