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10 дней назад

Director Quantitative Pharmacology

205 000 - 341 600$
Формат работы
hybrid
Тип работы
fulltime
Грейд
director
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
Director Quantitative Pharmacology (Pharmacometrics): Leading PK/PD evaluations and quantitative pharmacology support for research and development programs with an accent on regulatory strategy, quantitative analyses, and scientific reporting. Focus on developing regulatory submissions, interpreting pharmacometric data, and engaging with regulatory agencies through reviews and approvals.

Location: Hybrid, with four days per week onsite in Tarrytown, NY, Warren, NJ, or Cambridge, MA.

Salary: $205,000–$341,600 annually.

Company

hirify.global is a biotechnology company that discovers, develops, and commercializes medicines for serious diseases.

What you will do

  • Lead PK/PD evaluation for a portfolio of products or research and development projects.
  • Deliver quantitative analyses, interpretations, reports, and scientific messaging for pharmacometrics management.
  • Inform management about important program and regulatory developments.
  • Ensure the quality, accuracy, functional review, and senior-management readiness of study reports and related documents.
  • Develop meaningful scientific storylines and support quantitative pharmacology elements of regulatory strategy.
  • Author regulatory briefing books and CTD summaries and contribute to health authority meetings, negotiations, reviews, and approvals.

Requirements

  • PhD and 10+ years of experience in Quantitative Pharmacology, Pharmacometrics, or a related field.
  • Advanced knowledge of pharmacokinetic and pharmacodynamic principles, pharmacology, biology, quantitative drug development, and pharmaceutical development.
  • Deep understanding of scientific literature and extensive technical experience with PK/PD methods and quantitative tools.
  • Strong publication record in quantitative pharmacology or a related discipline.
  • Proven experience developing regulatory strategy and interacting independently with regulatory agencies.
  • Availability to work onsite four days per week at one of the specified U.S. locations.

Culture & Benefits

  • Inclusive workplace culture and equal employment opportunity.
  • Potential benefits include annual bonuses, incentive plans, equity awards, retirement benefits, 401(k) matching, health and wellness programs, insurance, paid time off, and family support benefits.
  • Reasonable accommodation is available during the recruitment process where required.

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