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6 дней назад

Senior Research Specialist TPK/PD

Формат работы
hybrid
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

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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

hirify.global 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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