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19 часов назад

Senior Scientist Drug Safety & Metabolism

106 200 - 167 200$
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

Текст:
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TL;DR
Senior Scientist Drug Safety & Metabolism (Veterinary Pharmaceuticals): Supporting the design, monitoring, analysis, and reporting of in vivo safety and residue studies for veterinary small-molecule pharmaceuticals with an accent on GLP compliance, data integrity, and regulatory submissions. Focus on coordinating CRO activities, reviewing raw data and study reports, and assembling submission-ready packages for global health authorities, especially the US FDA.

Location: Hybrid, Rahway, New Jersey; available to US, Canada, and Puerto Rico residents. Travel to CROs is required, approximately 10%.

Salary: $106,200–$167,200 per year, plus potential annual bonus and long-term incentive.

Company

hirify.global develops pharmaceutical products and conducts global preclinical development for human and animal health applications.

What you will do

  • Support the design, coordination, monitoring, and reporting of in vivo safety studies for companion animals and residue studies for livestock veterinary small-molecule pharmaceuticals.
  • Participate in protocol development, data-capture-form creation, CRO selection, study contracts, pre-study meetings, monitoring visits, and protocol training.
  • Collect, review, and monitor study documentation; prepare monitoring visit reports and track study activities with study leads.
  • Review raw data, phase reports, and final reports for completeness, data quality, data integrity, protocol compliance, SOPs, OECD, and GLP requirements.
  • Generate raw-data packages, finalize study reports, and assemble submission-ready packages for global health authorities, especially the US FDA.
  • Transfer completed study packages to the archivist or other document depositor.

Requirements

  • Bachelor of Science and at least four years of experience in veterinary sciences, toxicology/pharmacology, pharmacokinetics, biology, chemistry, biochemistry, or an equivalent field.
  • Recent experience within the last three years conducting and/or monitoring in vivo preclinical safety studies supporting registration of veterinary or companion-animal pharmaceuticals in an industrial setting or CRO.
  • Experience preparing and/or obtaining scientific reports from CROs and experience with Good Laboratory Practices.
  • Familiarity with applicable departmental SOPs, regulations, and guidelines, including VICH, GLP, 21 CFR Part 58, and OECD.
  • Excellent verbal and written communication, attention to detail, teamwork, and interpersonal skills.
  • Ability to multitask, manage competing priorities, meet established timelines, and adapt to rapidly shifting priorities.
  • Knowledge of standard office software, including Microsoft Word, Excel, PowerPoint, and SharePoint.
  • Required skills include automated liquid handling systems, bioanalytical method development and techniques, clinical judgment, data analysis, experimentation, flow cytometry, immunohistochemistry, research proposal development, scientific writing, and tissue culture techniques.

Nice to have

  • Working understanding of domestic and international regulations and guidance governing veterinary drug development for companion and food animals.
  • Knowledge of electronic data-capture systems and submission-package preparation.
  • Experience conducting, monitoring, reviewing, and/or summarizing residue and safety studies supporting domestic and international registration of veterinary pharmaceuticals.

Culture & Benefits

  • Hybrid work arrangement with regular collaboration across global preclinical development study teams.
  • Comprehensive medical, dental, vision, insurance, retirement, and 401(k) benefits.
  • Paid holidays, vacation, compassionate leave, and sick days.
  • Inclusive workplace focused on diverse perspectives, respectful challenge, and collective problem-solving.
  • Regular employee status; no relocation support and no visa sponsorship.

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