Job Description

Career Category

Clinical

■Job Summary

The 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 Responsibilities

• Optimize 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 Qualifications

• Knowledge/Skill
  • Strong knowledge of ADME and pharmacodynamics.
  • Familiarity with local regulatory documents in CTNs, J-NDAs, PMDA consultations
  • Excellent communication and collaboration skills in both English and Japanese
  • Ability to work independently and as part of a team.
• Experience
  • At least 5 years of drug development experience with expertise in clinical pharmacology
  • Experiences in regulatory interaction with PMDA, such as PMDA consultations and inspections
  • Experiences of collaboration with global teams
• Education
  • Master’s degree in pharmacology/pharmacokinetics or related scientific field

■Preferred Qualification

• Strong knowledge/experience in a disease area(s) of focus for Amgen, e.g., Inflammation, Cardiometabolic, rare disease, and Oncology
• PhD in pharmacology, pharmaceutical sciences, or a related field
• Knowledge/experience of electronic data submission for population pharmacokinetic/exposure-response analyses.
• Knowledge/experience of managing external venders