Join a global leader as part of the North America Product Safety team as a subject matter expert in pharmacokinetic (PK) / toxicokinetic (TK) studies for evaluating and driving data to aid in Human Safety risk assessments. This data driven role will address PBPK and ADME related issues and provide guidance concerning the compound progression.
— Design, conduct and interpret data from pharmacokinetic studies, ensuring the appropriate questions have been answered and communicate the meaning of data and its implication to the project team. Coordinate the delivery of studies conducted internally or externally to ensure project needs are met.
— Manage studies placed with CROs to ensure delivery and quality of data meet time and cost schedules
— Through participation in project teams contribute to key decisions and aid in compound selection
— Support the use of ADME data sets to optimize toxicology study design and overall understanding of the compound’s behavior in vivo
— Identify opportunities for improvement / development of modeling capabilities, e.g. in vitro to in vivo extrapolation, in silico tools, and PBPK models
— PhD or MS in Biological or Chemical Sciences with 8+ years experience in developing and managing pharmacokinetics and toxicokinetics studies in pharmaceutical, chemical, agrichemical, or EPA/ FDA organizations.
— Knowledge of molecule discovery and development in an industrial setting and the utilization of pharmacokinetics in this process
— Background knowledge of human toxicology studies and objectives
— Training and hands-on experience in pharmacokinetics modeling and analysis and demonstrated ability to work with modeling tools (e.g., NONMEM, Phoenix, GastroPlus, Simcyp)
— Ability to work in the USA without sponsorship, now or in the future