Key skills
RAIMLCollaboration
About this role
Role Overview
- Defining and executing model-based development strategies for oncology projects
- Planning, conducting and reporting exposure-response analysis, simulation-based trial design and dose selection
- Applying innovative methods such as drug-disease modeling, longitudinal exposure-response analysis
- Presenting strategy and defending outcome of model-based approaches to internal governance boards and regulatory agencies
- Write or review clinical pharmacology components of regulatory documents and responses
Requirements
- A PhD in Quantitative Clinical Pharmacology and Pharmacometrics (e.g., pharmacology, engineering or statistics)
- 5+ years of utilizing skills in mechanistic PKPD and longitudinal disease modelling
- verifiable proficiency in pharmacometric tools NONMEM or R
- 3+ years of experience in planning, performing, and reporting analysis of clinical data per industry and regulatory standards
- Expertise in applications of AI/ML in Clinical Pharmacology and Pharmacometric analyses
- Strong drive and learning agility to build knowledge on a drug-disease system
- Demonstrated aptitude for productive collaboration in a multi-discipline team
- Experience in the design, analysis, interpretation and reporting of Clinical Pharmacology studies per industry and regulatory standards
- Passion for quantitative clinical pharmacology
Benefits
- health care and other insurance benefits (for employee and family)
- retirement benefits
- paid holidays
- vacation
- paid caregiver/parental and medical leave