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3 дня назад

Associate Director, Clinical Pharmacology, Clinical and Quantitative Pharmacology (mRNA)

Формат работы
hybrid
Тип работы
fulltime
Грейд
director
Английский
b2
Страна
UK
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, Clinical Pharmacology, Clinical and Quantitative Pharmacology (mRNA): Developing integrated, model-informed clinical pharmacology strategies for mRNA therapeutics across oncology, immunology, and rare disease programs with an accent on dose selection, PK/PD analysis, translational evidence, and regulatory strategy. Focus on integrating nonclinical and clinical data, applying modeling and simulation to complex development questions, and translating quantitative findings into clinical and regulatory decisions.

Location: Oxford, England, United Kingdom. Hybrid 70/30 work model with 70% in-office collaboration.

Company

hirify.global develops an mRNA technology platform, medicines, and related research, laboratory, and manufacturing capabilities.

What you will do

  • Develop fit-for-purpose clinical pharmacology plans covering dose selection and optimization, PK/PD, immunogenicity, pediatric development, and lifecycle requirements.
  • Perform and evaluate PK/PD, exposure-response, modeling, and simulation analyses and translate findings into development recommendations.
  • Integrate nonclinical, translational, clinical, literature, external, and emerging program data into quantitative evidence for development decisions.
  • Partner with Pharmacometrics and Quantitative Systems Pharmacology colleagues on integrated analyses, model interpretation, and program-level decisions.
  • Represent Clinical Pharmacology on multidisciplinary program teams and contribute to protocols, INDs, BLA summary documents, briefing books, and regulatory interactions.
  • Support mRNA platform development across oncology, immunology, and rare disease, including appropriate use of Generative AI and advanced digital tools under scientific review and governance.

Requirements

  • PhD in Clinical Pharmacology, Pharmacometrics, Pharmaceutics, Statistics, Engineering, or a related field, plus at least 5 years of industry experience in clinical pharmacology, DMPK, or Pharmacometrics.
  • Practical expertise in quantitative pharmacology, including PK/PD modeling, exposure-response analysis, modeling and simulation, and translational PK/PD, with the ability to evaluate assumptions, results, and limitations.
  • Experience integrating nonclinical and clinical evidence for first-in-human predictions, dose selection and optimization, and regulatory decision-making.
  • In-depth knowledge of clinical pharmacology, PK/PD principles, drug disposition, ADME, and quantitative translational sciences.
  • Proficiency in data analysis, visualization, and pharmacokinetic or modeling software such as R, Phoenix WinNonlin, NONMEM, Monolix, or equivalent tools.
  • Strong verbal and written communication skills, independence, and ability to work in a highly matrixed team environment.
  • The role may require an enhanced pre-employment check.

Nice to have

  • Drug development experience in oncology is strongly preferred.
  • Expertise in immune therapeutics and/or rare diseases is a plus.

Culture & Benefits

  • In-person collaboration is emphasized through a 70/30 work model, with 70% of work conducted in the office.
  • Smoke-free, alcohol-free, and drug-free work environment.
  • Healthcare and voluntary benefit programs, fitness, mindfulness, and mental health support.
  • Family-building support, including fertility, adoption, and surrogacy benefits.
  • Paid vacation, bank holidays, volunteer days, sabbatical, global recharge days, and discretionary year-end shutdown.
  • Savings and investment programs plus location-specific benefits.

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