Clinical Pharmacology Manager
Core
Provide scientific guidance from clinical pharmacology aspects to drive Japan clinical development projects and author regulatory documents for PMDA submissions.
Role type
Senior IC clinical pharmacology manager (Japan)
Builds
Clinical development projects for Japan assets
Domain
Biopharmaceuticals, Clinical Pharmacology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical pharmacology expertise, Regulatory document authoring (CTDs, briefing books), Cross-functional collaboration, Due diligence assessment, Scientific meeting participation
Preferred skills
Ph.D. in relevant field, First-author publication experience, TOEIC 730+
Technologies
CTDs, PMDA systems
Responsibilities
Represent Clinical Pharmacology to drive projects forward, Author regulatory documents for PMDA interactions, Support due diligence assessments, Drive discussions to increase clinical pharmacology expertise, Participate in external scientific meetings
Seniority
Senior, hands-on IC with team leadership