6 дней назад
Senior Research Specialist TPK/PD
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Research Specialist TPK/PD (Pharmacokinetics/Pharmacodynamics): Performing non-compartmental and compartmental PK/PD analyses and preparing submission-ready datasets, tables, listings, and figures with an accent on pharmacometric analysis, CDISC SEND data, and GxP/GLP compliance. Focus on designing and supporting animal PK/TK studies, producing regulatory deliverables, and ensuring data integrity and traceable derivations.
Location: Tarrytown, New York; onsite four days per week
Company
is a biotechnology company developing and commercializing medicines for serious diseases through science-driven research and development.
What you will do
- Perform non-compartmental PK and compartmental PK/PD analyses for nonclinical and potentially clinical studies.
- Prepare and quality-control standardized CDISC SEND datasets from CRO and internal bioanalytical data.
- Support CRO studies by tracking requirements, priorities, status, and milestones across the study lifecycle.
- Contribute to pharmacometrics study design, analysis, and reporting deliverables.
- Produce submission-ready tables, listings, concentration-time profiles, and other regulatory figures using validated tools.
- Follow SOPs and maintain data integrity and GxP/GLP compliance.
Requirements
- Bachelor's degree with 2–4 years of relevant experience, or a Master's degree with 0–2 years of relevant experience.
- Understanding of pharmacokinetic concepts and techniques.
- Experience with Phoenix WinNonlin and related analysis software; knowledge of NLME may be relevant.
- Experience with animal PK/TK studies, including protocol design and study conduct.
- Ability to perform and explain advanced pharmacometric techniques and interpret results.
- Experience working in a GLP environment and following controlled SOPs.
Culture & Benefits
- Science-driven environment focused on developing life-changing medicines.
- Benefits may include annual incentives, equity awards, retirement benefits, health and wellness programs, insurance, paid time off, and family support benefits.
- Inclusive workplace with reasonable accommodation available during the recruitment process where required.
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