臨床薬理M&Sマネージャー/ Clinical Pharmacology M&S Manager

A global pharmaceutical company is looking for a Clinical Pharmacology Modeling & Simulation Manager. The selected candidate will drive clinical pharmacology strategies, support local drug development, and contribute to regulatory submissions.

Responsibilities:

• Optimise clinical pharmacology strategies for local drug development
• Collaborate with global and local cross-functional teams
• Apply clinical pharmacology principles to development plans
• Align development activities with local regulatory requirements
• Communicate clinical pharmacology findings to key stakeholders
• Support PMDA submissions and regulatory interactions

Requirements:

• Master’s degree or above in pharmacology/pharmacokinetics or related scientific field
• More than 5 years of drug development experience with expertise in clinical pharmacology
• Experience in regulatory interaction with PMDA, such as PMDA consultations and inspections
• Prior experience in collaboration with global teams
• Understanding of ADME and pharmacodynamics
• Knowledge of local regulatory documents in CTNs, J-NDAs, PMDA consultations
• Proficient in English and Japanese

Preferred requirements:

• PhD in pharmacology, pharmaceutical sciences, or a related field
• Experience in disease areas (inflammation, cardiometabolic, rare disease, and oncology)
• Prior experience of electronic data submission for population pharmacokinetic/exposure-response analyses
• Proven experience of managing external venders

About the Company:

A global pharmaceutical group, this organisation is an internationally recognised name in biotechnology. Responsible for a range of medicines aimed at treating human illnesses, this company supplies medical professionals and patients across the world.

Keywords:

製薬, メディカル, サイエンス, 求人, 外資系

Job Ref: MJHF0O