Senior Research Specialist – TPK/PD

Regeneron Pharmaceuticals; Tarrytown (GA); Presencial; USD 94.000 - 153.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Total rewards package

Descripción de la vacante

Regeneron Pharmaceuticals seeks a Senior Research Specialist, TPK-PD to join our nonclinical analysis team. You will conduct PK/PD analyses, prepare standardized datasets for regulatory submission, and ensure GxP compliance. You will contribute to protocol design and support CRO studies, delivering regulatory-ready tables and figures.

Based in Tarrytown, NY, the role requires onsite presence four days weekly and a strong background in pharmacokinetics, data handling, and CDISC SEND development.

Formación

• Bachelor’s degree required; 2–4 years of relevant experience or Master’s degree with 0–2 years of experience.
• Strong understanding of pharmacokinetics concepts and techniques.
• Experience in GLP environment and SOP adherence.

Responsabilidades

• Performs non‑compartmental PK and compartmental PK/PD analyses for nonclinical and potential clinical studies.
• Prepares and quality-controls CDISC SEND datasets from CRO and internal data.
• Supports CRO studies and coordinates with study teams across the lifecycle.
• Produces tables/listings and figures for regulatory submissions using validated tools.

Conocimientos

PK/PD analysis

Phoenix WinNonlin

GxP/GLP

CDISC SEND

Data QC

R

Educación

Bachelor’s degree

Master’s degree

Herramientas

NLME

Descripción del empleo

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 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

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 accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

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 on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

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

Salary Range (annually)

$93,900.00 - $153,300.00