Career CategoryClinicalJob Description■Job SummaryThe Clinical Pharmacology Modeling & Simulation Manager will be responsible for developing and implementing clinical pharmacology strategies to support drug development programs. The successful candidate will be local representative of CPMS for the assigned programs, and provide clinical pharmacology expertise to global and local teams.Key ResponsibilitiesOptimize clinical pharmacology components in local drug developments.Collaborate with global and local cross-functional teams.Apply clinical pharmacology principles and regulatory requirements to local drug development.Effectively Communicate clinical pharmacology results to internal and external stakeholders.Contribute to regulatory submissions and interactions with PMDA.■Basic QualificationsKnowledge/SkillStrong knowledge of ADME and pharmacodynamics.Familiarity with local regulatory documents in CTNs, J-NDAs, PMDA consultationsExcellent communication and collaboration skills in both English and JapaneseAbility to work independently and as part of a team.ExperienceAt least 5 years of drug development experience with expertise in clinical pharmacologyExperiences in regulatory interaction with PMDA, such as PMDA consultations and inspectionsExperiences of collaboration with global teamsEducationMaster’s degree in pharmacology/pharmacokinetics or related scientific field■Preferred QualificationStrong knowledge/experience in a disease area(s) of focus for Amgen, e.g., Inflammation, Cardiometabolic, rare disease, and OncologyPhD in pharmacology, pharmaceutical sciences, or a related fieldKnowledge/experience of electronic data submission for population pharmacokinetic/exposure-response analyses.Knowledge/experience of managing external venders.