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1 день назад

Associate Director, Quantitative Pharmacology, Clinical Pharmacology

169 222 - 253 000$
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, Quantitative Pharmacology, Clinical Pharmacology (PK/PD and Drug Development): Providing clinical pharmacology input across small- and large-molecule development from pre-IND through regulatory submissions with an accent on clinical study design, PK/PD analysis, and cross-functional drug development. Focus on developing model-based drug development strategies, interpreting exposure-response data, authoring regulatory documents, and coordinating pharmacology activities across bioanalytical, formulation, and pharmacometrics teams.

Location: Remote within the United States; travel up to 15%

Salary: $169,222–$253,000 annually, plus incentive opportunity

Company

hirify.global is a pharmaceutical company developing small- and large-molecule medicines across multiple therapeutic areas.

What you will do

  • Provide clinical pharmacology input across pre-IND, IND, Phase 1–3, PK, PK/PD, and regulatory activities.
  • Lead clinical pharmacology work on cross-functional project teams, including study design, protocol development, execution, reporting, and data interpretation.
  • Conduct translational and clinical PK and PK/PD analyses, including noncompartmental, correlation, exposure-response, and meta-analysis work.
  • Support pharmacometrics, modeling and simulation, and model-based drug development strategies.
  • Author clinical pharmacology sections for IND/NDA applications, investigator brochures, annual reports, pediatric development plans, and scientific publications.
  • Coordinate bioanalytical, formulation, outsourcing, budget, statement-of-work, and invoice approval activities.

Requirements

  • PhD, PharmD, or MS in Clinical Pharmacology or a related field, with at least 4 years of industry experience.
  • In-depth knowledge of clinical pharmacology, PK, PD, drug metabolism, biopharmaceutics, and bioanalytical chemistry.
  • Hands-on PK and PK/PD analysis experience using software such as Phoenix NLME and R.
  • Working knowledge of Phase I clinical operations, drug development, multi-region regulatory requirements, and PK/PD analysis.
  • Strong scientific problem-solving, organization, communication, and collaboration skills.
  • Must be eligible to perform the role in the United States.

Nice to have

  • Experience in population PK and PK/PD modeling.
  • Experience with statistical models.

Culture & Benefits

  • Cross-functional collaboration with clinical, non-clinical, bioanalytical, formulation, pharmacometrics, and business development groups.
  • Comprehensive medical, dental, vision, and prescription drug coverage.
  • Company-provided life and disability insurance.
  • Tuition reimbursement and student loan assistance.
  • 401(k) match, flexible time off, paid holidays, and paid leave programs.

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