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4 дня назад

Senior Scientist, Pharmacometrics

109 000 - 174 800$
Формат работы
onsite
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, Pharmacometrics (PK/PD modeling and simulation): Executing population pharmacokinetic, pharmacodynamic, and exposure-response modeling and simulation for compounds in development with an accent on dose regimen selection, clinical study design, and regulatory submissions. Focus on defining analysis plans, conducting quality control, preparing regulatory documents, and developing pharmacometrics methodologies.

Location: Raritan, New Jersey, United States of America, or Spring House, Pennsylvania, United States of America. The role includes approximately 5% domestic and international travel.

Salary: $109,000–$174,800 annually.

Company

Johnson & Johnson MedTech develops healthcare solutions and medicines intended to prevent, treat, and cure complex diseases.

What you will do

  • Conduct population PK, PD, and exposure-response analyses to support dose selection and drug development decisions.
  • Support clinical study design, model-informed drug development plans, and regulatory submissions.
  • Write analysis plans and reports, define data requirements, conduct analyses, and perform quality control checks.
  • Manage pharmacometrics deliverables within a matrix environment, project timelines, and overall program goals.
  • Prepare regulatory documents and responses for Agency questions, Regulatory Agency meetings, and Advisory Committee Meetings.
  • Present scientific work, publish manuscripts, contribute to methodology development, and support software validation and process improvement.

Requirements

  • Ph.D. or equivalent in Pharmaceutical Sciences, Pharmacometrics, Chemical Engineering, Biomedical Engineering, or Biological Sciences; or an M.S. degree with 2+ years of experience.
  • Basic knowledge of PK and PK/PD modeling and simulation concepts and methods.
  • Knowledge of NONMEM and/or Monolix and R.
  • General understanding of the overall drug development process.
  • Good oral and written communication skills.
  • Ability to work from the listed United States locations and travel approximately 5% domestically and internationally.

Nice to have

  • Experience with clinical pharmacology, pharmacokinetic modeling, scientific research, report writing, clinical data management, or clinical trials operations.
  • Experience presenting at scientific meetings, publishing in peer-reviewed journals, or participating in professional society special interest groups.

Culture & Benefits

  • Work in a science-driven healthcare environment focused on developing medicines and improving patient outcomes.
  • Collaborate in a matrix organization with cross-functional project teams.
  • Follow established SOPs, departmental processes, regulatory requirements, and Johnson & Johnson Credo principles.
  • Inclusive employment environment and equal opportunity practices.

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