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Associate Director, Quantitative Pharmacology And Pharmacometrics Immune / Oncology (Remote)
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- Associate Director, Quantitative Pharmacology and Pharmacometrics – Immune/Oncology (Remote)
- team in the role of Associate Director QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to clinical pharmacology and pharmacometrics of oncology drugs from post-PCC to registration.
- Developing and executing model-based analyses including translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial simulation, disease progression models, quantitative systems pharmacology (QSP) modeling, comparator modeling, thereby strengthening pharmacometrics capabilities on a continuous basis in decision making and driving pipeline impact.
- Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications (CTDs
- Ph. D. with 1-3 years of pharmaceutical drug development experience relating to: PKPD, pharmacometrics, mathematics, statistics/ biostatistics, or chemical/biomedical engineering.
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