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2 дня назад

Associate Director, Pharmacometrics

164 000 - 246 000$
Формат работы
remote (только USA)
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
Associate Director, Pharmacometrics (Pharmacometrics/PK-PD): Leading population PK, PK/PD, exposure-response analysis, and pharmacometrics strategy for international drug development programs with an accent on modeling, simulation, clinical study design, and regulatory submissions. Focus on developing dose-selection and optimization models, integrating Model Informed Drug Development principles, and supporting programs from research through registration and commercialization.

Location: Remote/Home-Based in the United States; listed locations are Palo Alto, CA and Philadelphia, PA

Base pay for US-based candidates: $164,000–$246,000 annually, plus potential bonus, equity, and benefits.

Company

hirify.global is a global biopharmaceutical company developing medicines for serious diseases, with a portfolio spanning sleep disorders, epilepsy, oncology, and neuroscience.

What you will do

  • Develop pharmacometrics strategies for multiple portfolio programs from research through registration and beyond.
  • Design, perform, interpret, and report population PK, PK/PD, and exposure-response analyses.
  • Provide hands-on modeling and simulation support for dose selection, optimization, and clinical development.
  • Support clinical study protocol design, data analysis, reporting, CSRs, and regulatory documents for Phase 1–4 studies.
  • Prepare development plans and regulatory submissions, respond to agency queries, and support inspections.
  • Manage pharmacometrics consultants and vendors and contribute to cross-functional Model Informed Drug Development activities.

Requirements

  • PhD in pharmaceutical sciences, biomedical engineering, clinical pharmacology, or mathematical/statistical sciences, with 5+ years of experience analyzing clinical pharmacokinetic and pharmacokinetic-pharmacodynamic data.
  • Strong understanding of clinical pharmacology, pharmacometrics principles, and the drug development process.
  • Experience performing PK/PD modeling and simulation using software such as NONMEM, Monolix, Phoenix WinNonlin, R, GastroPlus, SimCYP, ADAPT, or PK-Sim.
  • Ability to work independently and collaboratively in a multidisciplinary team environment.
  • Ability to succeed in a fast-paced, highly matrixed work environment.
  • Excellent written and oral communication, including presentation skills.
  • Ability to embody and model Jazz core values.

Nice to have

  • Experience interacting with regulatory agencies.

Culture & Benefits

  • Remote/home-based role supporting international drug development programs.
  • Cross-functional collaboration in a multidisciplinary and highly matrixed environment.
  • US-based employees may receive medical, dental, and vision insurance, a 401(k) retirement savings plan, and flexible paid vacation.
  • Potential eligibility for discretionary annual cash bonus or incentive compensation and equity grants.
  • Equal opportunity employer.

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