Pharmacokineticist, PPK​/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 Pharmacokineticist for PPK/PD to serve as a senior independent contributor in the Translational Pharmacokinetics and Pharmacodynamics (TPK/PD) Group, taking ownership of PK/PD analyses end-to-end and serving as a pharmacokinetics point of contact across assigned studies. This person will independently plan and execute 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 lead PK/TK protocol design/input, support CRO studies, produce Pharmacometrics deliverables and regulatory tables/figures/listings, contribute to standard‑setting and best practices for the group, and mentor and provide technical guidance to junior analysts, following all SOPs to ensure GxP/GLP compliance.

This role will sit at our Tarrytown, NY office and is expected to be on‑site 4 days per week.

• Independently leads, performs, and takes ownership of non‑compartmental PK and compartmental PK/PD analyses in support of nonclinical and (potentially) clinical studies, according to GxP as appropriate, and serves as the pharmacokinetics point of contact and lead analyst for assigned studies.
• Conducts compliance‑related activities (SOPs, etc.); ensures regulatory‑submission conformance, data integrity, and GxP compliance; adheres to controlled SOPs; helps set group standards by authoring/revising SOPs and providing senior compliance review of others' deliverables; and meets mandatory‑training and data‑confidentiality requirements.
• Owns the preparation, quality control, and senior review of 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, and sets and maintains the dataset standards and conventions the group follows.
• Owns and leads CRO study support; tracks study requirements, project priorities, status, and milestones; serves as the primary PK point of contact and liaison to CROs and functional groups; and drives coordination across the study lifecycle.
• Independently owns and executes a broad array of work supporting department priorities in routine and non‑routine Pharmacometrics deliverables on study design, analysis, and reporting, and sets methodology and best‑practice standards for the group.
• 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), and owns, sets, and reviews against the group's consistent, submission‑ready presentation standard.
• Produces and reviews figures and graphical outputs (e.g., concentration‑time profiles) for study reports and regulatory submissions using validated tools, and owns and sets the group's graphical presentation standard.

• Bachelors degree with 5-7 years of professional experience, or a Masters degree with 3-5 years of professional experience
• Strong, in‑depth understanding of pharmacokinetics concepts and techniques
• Proficient in relevant software, including Phoenix Win Nonlin; knowledge of NLME/population PK a plus
• Experience in animal PK/TK studies, including protocol design & study conduct
• Able to clearly describe and perform advanced pharmacometric techniques, interpret results independently, and mentor and provide technical…