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2 дня назад

Principal Pharmacokinetics Scientist

Формат работы
remote (только USA)
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
Principal Pharmacokinetics Scientist (Clinical Pharmacology/PK-PD Modeling): Designing and analyzing clinical pharmacology studies, PK/PD models, and regulatory submission materials with an accent on pharmacokinetic-pharmacodynamic analysis, modeling software, and protocol development. Focus on leading study concepts, integrating complex data into regulatory filings, mentoring pharmacologists, and guiding cross-functional client projects.

Location: United States; permanent remote role

Company

hirify.global is a global full-service contract research organization supporting pharmaceutical, biotechnology, medical device, and consumer health companies with clinical development and functional solutions.

What you will do

  • Lead study concept development, protocol design, clinical pharmacology development plans, and modeling and simulation plans.
  • Conduct PK-PD, population PK-PD, and related analyses supporting clinical trials, regulatory filings, publications, and presentations.
  • Use Phoenix WinNonlin, NLME, R/RStudio, Monolix, NONMEM, and similar PK/PD analysis tools.
  • Collaborate with clients and cross-functional teams, including bioanalytical scientists, biostatisticians, and clinical operations.
  • Prepare and review PK/PD analysis reports and provide expert guidance on clinical pharmacology and regulatory requirements.
  • Mentor junior pharmacologists and contribute to clinical pharmacology best practices.

Requirements

  • PhD in pharmaceutical sciences, pharmacology, life sciences, clinical pharmacology, pharmacokinetics, or a related field with at least 3 years of relevant experience; or PharmD with at least 5 years; or a relevant Master’s degree with at least 7 years.
  • Relevant experience in clinical pharmacology and pharmacokinetic-pharmacodynamic modeling and simulation within the pharmaceutical or biotechnology industry.
  • Strong knowledge of pharmacokinetics, pharmacodynamics, translational sciences, and PK/PD data analysis.
  • Hands-on expertise with Phoenix WinNonlin, NLME, R/RStudio, Monolix, NONMEM, or similar software.
  • Strong communication and organizational skills, including the ability to present complex data to scientific and non-scientific audiences.
  • Ability to manage multiple projects in a dynamic, client-oriented environment.

Nice to have

  • Experience across multiple therapeutic areas.
  • Prior experience in a CRO setting.
  • Certifications in clinical pharmacology or a related discipline.

Culture & Benefits

  • Permanent remote work with a collaborative, quality-focused one-team culture.
  • Professional development supported by continuous training and mentorship.
  • Work with projects across pharmaceutical, biotechnology, medical device, and consumer health portfolios.
  • Equal opportunity workplace focused on diversity and inclusion.

Hiring process

  • Submit a CV and receive an application acknowledgement.
  • Selected candidates are invited to a phone interview as the first step.

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