Senior Research Specialist – TPK/PD

Role: Senior Research Specialist in TPK-PD supporting nonclinical analysis within Regeneron's Translational PK-PD team, focusing on pharmacokinetic/pharmacodynamic data analysis for nonclinical and clinical studies. Responsibilities include performing non-compartmental and compartmental PK/PD analyses using Phoenix WinNonlin, preparing and QC'ing regulatory-standard datasets from CRO and internal bioanalytical data, supporting CRO studies throughout their lifecycle, and producing regulatory tables, figures, and summaries for submissions. The role requires adherence to GxP/GLP standards and SOPs, ensuring data integrity and compliance.

Qualifications: Bachelor's degree with 2-4 years or Master’s with 0-2 years relevant experience; strong understanding of pharmacokinetics concepts; proficiency with Phoenix WinNonlin and possibly NLME; experience in animal PK/TK studies, including protocol design and execution; capable of interpreting advanced pharmacometric analyses in a GLP environment.

High-Value: Focus on nonclinical PK/PD, regulatory data preparation, GxP/GLP compliance, and supporting pharmacometrics deliverables in a science-driven organization. The position involves cross-functional collaboration across study design and data analysis functions.

Work Setup: Onsite in Tarrytown, NY, four days per week.