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.

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 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.

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 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

Does 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.

Where necessary, we disclose salary ranges for roles in all countries in which we operate.  The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.  Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.  If you have any questions, please speak with your recruiter. 

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)