R&D Clinical Pharmacology Early Clinical Scientist
Core
Designing and executing clinical pharmacology strategies for early development projects, including formulation development and regulatory submissions to PMDA.
Role type
Senior IC clinical pharmacologist (early clinical development)
Builds
Clinical development strategies, regulatory submission packages (CTD), and study protocols for pharmaceutical products.
Domain
Pharmaceutical industry, clinical pharmacology, regulatory affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical development strategy, Clinical trial planning, Medical writing, Regulatory submissions (CTD), Pharmacodynamics, Pharmacogenetics, Pharmacogenomics, Protocol development, Translational medicine, ICH GCP compliance
Preferred skills
Study management, CRA experience, Formulation development expertise
Technologies
CTD, ICH GCP Guidelines
Responsibilities
Develop clinical pharmacology strategies for early development; Create clinical trial protocols and informed consent documents; Prepare regulatory submission materials for PMDA; Conduct medical review of clinical trial data; Negotiate with vendors for trial materials.
Seniority
Senior, hands-on IC
