Senior Research Specialist – TPK​/PD

Build Our Future Together 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 Win Nonlin 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.

When & Where This role is based in our Tarrytown, NY office and will be onsite four days per week.

Discover Your Role 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 Win Nonlin, 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.

This Role Requires 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 Win Nonlin; may include knowledge of NLMEExperience 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 SOPsDoes this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all  qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.

Where required, we will provide reasonable…