R&D Clinical Pharmacology Early Clinical Scientist

About the role

The role supports the design and execution of early clinical pharmacology programs within MSD's R&D organization. You will work on strategy, regulatory documentation, and trial execution from early development through approval.

Key responsibilities

• Develop early clinical development and formulation strategies, including clinical pharmacology plans up to regulatory submission.
• Prepare PMDA consultation documents and respond to regulator inquiries.
• Draft clinical trial protocols, consent forms, case report forms and related SOPs.
• Coordinate trial materials, negotiate with domestic and overseas vendors, and conduct medical review of trial data.
• Create clinical pharmacology sections of CTD dossiers and post‑approval inquiry responses.

Required profile

• 3–15 years of experience in pharmaceutical clinical development.
• Strong communication skills for collaboration with internal teams and external partners.
• Proficiency in English for written and verbal interaction with US headquarters and overseas vendors.
• Academic background in pharmacy, life sciences or a related discipline.

Required skills

• Clinical Development
• Clinical Study Management
• ICH GCP Guidelines
• Medical Writing
• Pharmaceutical Development
• Pharmacodynamics
• Pharmacogenetics / Pharmacogenomics
• Protocol Development
• Regulatory Submissions
• Scientific Publications
• Translational Medicine