Developing and executing clinical pharmacology strategies for small molecules and biologics assets
Providing clinical pharmacology expertise in characterizing pharmacokinetics and absorption, distribution, elimination profiles
Justifying dose selection
Assessing drug/food interaction potential
Characterizing QT prolongation potential
Planning and reviewing study designs & analysis plans
Analyzing & interpreting pharmacokinetic and pharmacodynamic data
Developing clinical pharmacology study designs and collaborating with CROs and Clinical Operations
Contributing to the design and analysis of PK data from patient clinical studies
Performing population PK (PPK) analyses
Conducting exposure–response (ER) analyses
Analyzing, interpreting, summarizing and presenting data to internal project teams and to senior management
Assisting in authoring relevant sections of IND/CTA filings as well as NDA/MAA/BLA submissions

A PhD or M.S. in Pharmacokinetics, Pharmaceutical Sciences/Pharmacy, Biomedical Engineering, Bioinformatics, Data Sciences, Mathematics, or related STEM discipline
4+ years relevant work experience
Proficiency in using R for data manipulation, visualization, and basic statistical analyses
Exposure to working with and manipulating large datasets
Hands-on experience in performing NCA using Phoenix WinNonlin or PK-NCA
Experience with NONMEM, Monolix, Berkeley Madonna, Simcyp, Gastroplus preferred
Demonstrated commitment to problem solving and developing creative solutions
Detail oriented
Ability to multi-task
Ability to adapt to fast-moving timelines and quick turnaround times
Strong written and oral communication skills
Strong drive to learn and apply emerging technologies such as AI, ML, or other tools to improve daily task efficiencies

Manager, Clinical Pharmacology – Pharmacometrics

Key skills