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About the Role
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 role involves planning and executing PK/PD analyses, preparing datasets for regulatory submission, leading protocol design, supporting CRO studies, producing Pharmacometrics deliverables, mentoring junior analysts, and ensuring GxP/GLP compliance.
Responsibilities
- Independently leads, performs, and takes ownership of non-compartmental PK and compartmental PK/PD analyses.
- Serves as the pharmacokinetics point of contact and lead analyst for assigned studies.
- Conducts compliance-related activities, ensuring regulatory-submission conformance, data integrity, and GxP compliance.
- Helps set group standards by authoring/revising SOPs and providing senior compliance review of others' deliverables.
- Owns the preparation, quality control, and senior review of standardized CDISC SEND datasets.
- Sets and maintains the dataset standards and conventions the group follows.
- Owns and leads CRO study support, tracking study requirements, project priorities, status, and milestones.
- Serves as the primary PK point of contact and liaison to CROs and functional groups.
- 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.
- Sets methodology and best-practice standards for the group.
- Produces and formats tables and listings (TFLs) for regulatory documents using validated tools.
- Owns, sets, and reviews against the group's consistent, submission-ready presentation standard.
- Produces and reviews figures and graphical outputs for study reports and regulatory submissions using validated tools.
- 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 is a plus.
- Experience in animal PK/TK studies, including protocol design & study conduct.
- Able to clearly describe and perform advanced pharmacometric techniques.
- Able to interpret results independently.
- Able to mentor and provide technical guidance to junior staff.
- Ability to help set group standards and best practices.
- Experience working in a GLP environment and following SOPs.
- Background checks may be conducted in accordance with applicable laws.
Skills
- Phoenix WinNonlin
- NLME/population PK
- Pharmacokinetics
- Pharmacodynamics
- PK/PD analyses
- Non-compartmental PK
- Compartmental PK/PD analyses
- CDISC SEND datasets
- Pharmacometrics
- R
Location
- Tarrytown, NY
Work Type
- On-site (4 days per week)
Experience Level
- 5-7 years (Bachelors)
- 3-5 years (Masters)
Education Level
- Bachelors degree
- Masters degree
Salary/Compensations
- $109,900.00 - $179,300.00
Benefits
- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits (medical, dental, vision, life and disability)
- Paid time off
- Family support benefits
About the Company
- Regeneron uses science and innovation to develop life-changing medicines for people with serious diseases.
- We are committed to building a workplace with an inclusive culture.
- We believe we do our best work when we are together.
Equal Opportunity
- 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.