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Lead2Impact - Merck
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- Job Description Role and Responsibilities: We are seeking an experienced talented scientist to join the Quantitative Pharmacology and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of 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.
- Directors are leaders in the field of quantitative drug development, with a strong, integrated understanding of the strategic elements of drug development.
- Developing and executing model-based analyses including translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial design simulation, disease progression models, quantitative systems pharmacology (QSP) modeling into programs, comparator modeling, thereby strengthening our 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
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