Pharmacokineticist, PPK/PD

Regeneron Pharmaceuticals, Inc (USA); Village of Tarrytown (NY); On-site; USD 110,000 - 179,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in Tarrytown, NY is seeking a Pharmacokineticist for PPK/PD to own end-to-end PK/PD analyses in nonclinical and potentially clinical studies, using Phoenix WinNonlin and other tools, with data preparation for regulatory submissions.

The role requires a Bachelor’s with 5–7 years or a Master’s with 3–5 years, strong PK knowledge, GLP/GxP experience, and CRO collaboration. The position is on-site in Tarrytown, NY and expects four days per week in the office, with

Qualifications

• Strong, in-depth understanding of pharmacokinetics concepts and techniques.
• Experience leading PK/PD analyses in GLP/GxP environments.
• Ability to mentor junior staff and drive data integrity for regulatory submissions.

Responsibilities

• Lead end-to-end PK/PD analyses for nonclinical and potential clinical studies.
• Prepare and QC standardized datasets for regulatory submissions.
• Design PK/PD protocols and support CRO studies across the study lifecycle.
• Produce and review regulatory tables, listings and figures (TLFs) using validated tools.

Skills

Pharmacokinetics concepts

Data analysis

Mentoring

GLP SOPs

Education

Bachelor's degree

Master's degree

Tools

Phoenix WinNonlin

R

NLME

Job description

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 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 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.

When & Where: This role will sit at our Tarrytown, NY office and is expected to be on-site 4 days per week.

Discover Your Role:

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 WinNonlin, 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.

This Role Requires:

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 WinNonlin; 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 guidance to junior staff

Ability to help set group standards and best practices, with experience 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.

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
• 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.

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) $109,900.00 - $179,300.00

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.