About Daiichi Sankyo Cancer Enterprise
The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA.
The purpose of this position is to conduct population PK/PD analysis for pooled Phase 1 studies, perform trial simulation for Phase 2/3 studies, and write M&S reports. This position demonstrates significant knowledge of pooled Phase 1 studies, PK/PD and biomarker data, PK/PD analysis-ready data file derivation, complex disease modalities, regulatory guidelines pertaining to M&S, and programming and analytical software. This position works independently on complex studies/models and interacts effectively with project team members, CRO, and regulatory agencies.
Analyzes and presents pooled Phase 1 studies while delivering best practice elements and driving global standards
Conducts trial simulations for Phase 2/3 studies; characterizes the time course of disease progression for complex disease modalities
Writes M & S documents (e.g. M&S report, analysis plan, dataset specification)
Works independently on complex studies/models while interacting effectively with internal colleagues, external CROs, as well as regulatory agencies
Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Director Modeling and Simulation QCP
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