Senior Research Specialist – TPK/PD

Regeneron Pharmaceuticals•Tarrytown, GA

9d•$93,900 - $153,300•Hybrid

About The Position

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Research Specialist, TPK-PD to join our nonclinical analysis team supporting our Translational PK-PD organization. In this role, you will perform non-compartmental and compartmental PK/PD analyses in support of nonclinical and (potentially) clinical studies using Phoenix WinNonlin and other analysis software and will prepare and quality-control standardized datasets from CRO and internal bioanalytical data for regulatory submission. This person will contribute to PK/TK protocol design/input, support CRO studies, produce Pharmacometrics deliverables and regulatory tables/figures/listings, and follow all SOPs to ensure GxP/GLP compliance. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Requirements

Bachelor's degree and 2-4 years of relevant experience, or a Master's degree with 0-2 years of relevant experience
An understanding of pharmacokinetics concepts and techniques
Skilled in the use of relevant software, including Phoenix WinNonlin; may include knowledge of NLME
Experience in animal PK/TK studies, including protocol design & study conduct
Able to clearly describe and perform advanced pharmacometric techniques and interpret results
Experience in working in a GLP environment and following SOPs

Responsibilities

Performs non-compartmental PK and compartmental PK/PD analyses in support of nonclinical and (potentially) clinical studies, according to GxP as appropriate.
Conducts compliance-related activities (SOPs, etc.); ensures regulatory-submission conformance, data integrity, and GxP compliance; adheres to controlled SOPs; and meets mandatory-training and data-confidentiality requirements.
Prepares and quality-controls standardized CDISC SEND datasets (e.g., PC/PP domains and associated SUPPQUAL) from CRO and internal bioanalytical data, with auditable, source-traceable derivations that conform to controlled terminology and regulatory-submission standards.
Supports CRO studies; tracks study requirements, project priorities, status, and milestones; and coordinates with functional groups across the study lifecycle.
Independently executes a broad array of work supporting department priorities in routine Pharmacometrics deliverables on study design, analysis, and reporting.
Produces and formats tables and listings (TFLs), including PK concentration and parameter summaries, for regulatory documents using validated tools (e.g., Phoenix WinNonlin, R), to a consistent, submission-ready presentation standard.
Produces figures and graphical outputs (e.g., concentration-time profiles) for study reports and regulatory submissions using validated tools.