Principal Scientist, Clinical Pharmacokinetics & Pharmacometrics

About the role

MSD is looking for a Principal Scientist for its CP2 group in Tokyo, responsible for leading clinical pharmacology and pharmacometrics across drug development. The role leads scientific strategy, trial design, dosing selection and regulatory strategy, and acts as People Manager of the CP2 team.

Key responsibilities

• Lead the clinical pharmacology and pharmacometrics expertise in drug development strategy, clinical trial design, dosing selection and regulatory strategy
• Promote Model-Informed Drug Development using PK, PK-PD, Population PK, Exposure-Response and PBPK modeling and simulation
• Lead regulatory activities such as PMDA consultation, approval applications, queries and electronic data submissions
• Engage continuously with global stakeholders to connect Japan strategy with global development
• Manage the team's workload, resources and priorities, and support growth through coaching, feedback and mentoring
• Build a collaborative team environment and lead capability building and talent development in clinical pharmacology and pharmacometrics

Required profile

• PhD in life sciences, pharmacy, medicine or pharmacometrics
• At least 10 years of hands-on experience in clinical pharmacology or related fields at a pharmaceutical company
• People manager or equivalent leadership experience, including mentoring members
• Ability to discuss, propose and agree with global stakeholders in English

Required skills

• Knowledge of clinical pharmacology, PK/PK-PD, modeling and simulation (population PK, exposure-response) and non-clinical ADME
• Experience performing or overseeing population PK, PK-PD, exposure-response and PBPK analyses
• Experience with PMDA consultation, approval applications, CTD preparation, queries and electronic data submissions