Senior Principal Scientist, Clinical Expert in Pharmacokinetics - all genders
Core
Lead quantitative pharmacology programs and strategies for global R&D projects from research through registration, supporting in-licensing and product development.
Role type
Senior Principal Scientist, Clinical Expert in Pharmacokinetics
Builds
Global R&D projects, registration dossiers, and drug development pipelines
Domain
Pharmaceutical development, clinical pharmacology, regulatory affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
pharmacokinetic/statistical analysis of clinical data, regulatory interactions (FDA/EMA), protocol and analysis plan development, PBPK modeling, population PK/PD analysis
Preferred skills
software for physiology-based PK modelling (PK-Sim, SimCyp), NonMem, R
Technologies
Phoenix, PK-Sim, SimCyp, NonMem, R
Responsibilities
Develop and monitor execution of Quantitative Pharmacology programs; Lead global Translational Medicine and/or Quantitative Pharmacology sub-teams; Review and/or conduct PK, PK/PD, population PK/PD, and PBPK analyses; Provide input to regulatory documents and interact with health authorities
Seniority
Senior, hands-on IC with leadership responsibilities
