Pharmacokineticist, PPK/PD
Regeneron Pharmaceuticals
Summary
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.
Job description
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.
Requirements
- 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
Benefits
- Annual Bonuses
- Incentive Plans
- Equity Awards
- Pension Or Retirement Benefits
- 401(k) Company Match
- Health And Wellness Programs
- Fitness Centers
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Disability Insurance
- Paid Time Off
- Family Support Benefits
Company overview
Regeneron Pharmaceuticals is a leading American biotechnology company founded in 1988 and headquartered in Tarrytown, New York. The company specializes in inventing, developing, and commercializing life-transforming medicines for people with serious diseases. Regeneron is renowned for its innovative antibody technologies and has developed several groundbreaking therapies, including EYLEA® for retinal diseases, DUPIXENT® for inflammatory conditions, and the COVID-19 antibody cocktail REGEN-COV®. The company operates with a strong focus on research and development across multiple therapeutic areas including ophthalmology, oncology, cardiovascular diseases, and rare genetic disorders. Regeneron's proprietary VelocImmune® technology platform enables the rapid generation of fully human monoclonal antibodies. With over 15,000 employees globally and annual revenues exceeding $14 billion, Regeneron has established itself as a major force in the biotechnology industry, consistently ranking among the top-performing pharmaceutical companies and maintaining a robust pipeline of investigational therapies.