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2 часа назад

Associate Director/Director (Clinical Pharmacology)

164 000 - 205 000$
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/Director (Clinical Pharmacology): Designing and executing clinical pharmacology strategies for oncology small-molecule programs with an accent on PK/PD study design, dose selection, and regulatory documentation. Focus on applying PBPK, population PK, exposure-response modeling, and DDI assessment to support clinical development and health authority interactions.

Location: Remote - US; San Diego headquarters

Salary: Associate Director $164K–$205K; Director $196K–$245K per year

Company

hirify.global is a clinical-stage life-science and technology company developing medicines through an AI-driven discovery and development platform.

What you will do

  • Design and execute clinical pharmacology strategies for oncology small-molecule programs from IND-enabling activities through Phase 1 and later development.
  • Analyze and interpret clinical PK, PK/PD, and exposure-response data across multidisciplinary development teams.
  • Design first-in-human, drug-drug interaction, hepatic and renal impairment, food-effect, cardiac safety, and combination-therapy studies.
  • Apply PBPK, population PK, and exposure-response modeling to support dose selection and DDI risk assessment.
  • Author and review protocols, investigator brochures, SOPs, statistical analysis plans, clinical study reports, regulatory submissions, and responses to health authority queries.
  • Contribute to scientific publications and mentor junior scientists within the clinical pharmacology function.

Requirements

  • PhD or equivalent in pharmacology, biomedicine, biochemistry, or a related scientific discipline, with at least 5 years of relevant pharmaceutical, contract research, or clinical research experience.
  • Experience with clinical development of oncology small-molecule therapeutics, including dose-escalation, dose-expansion, and combination-therapy trials.
  • Proficiency with Phoenix WinNonlin for non-compartmental analysis.
  • Working knowledge of PBPK modeling, ICH M12, FDA DDI guidance, and related regulatory frameworks.
  • Hands-on experience writing clinical and regulatory documentation, plus strong project management and cross-functional communication skills.

Nice to have

  • Familiarity with PK bioanalytical method development and validation.

Culture & Benefits

  • Inclusive environment focused on collaboration, diversity, and teamwork.
  • Company-paid healthcare, flexible spending accounts, voluntary life insurance, and 401(k) matching.
  • Uncapped vacation.
  • San Diego facility with an onsite gym and dining.

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