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4 дня назад

Director, Clinical Pharmacology (Pharmacometric Modeling)

212 900 - 297 000$
Формат работы
hybrid
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
Director, Clinical Pharmacology (Pharmacometrics): Leading clinical pharmacology and pharmacometric strategies for rare disease and oncology drug development programs with an accent on clinical study design, regulatory submissions, and dose selection. Focus on population PK, PK-PD and exposure-response modeling, simulation, and solving complex drug development questions across clinical development phases.

Location: New York, New York or Salt Lake City, Utah preferred; remote work is considered for U.S. locations with regular on-site visits required.

Salary: $212,900–$297,000 annual base salary, plus annual bonus and equity compensation.

Company

hirify.global is a clinical-stage TechBio company developing investigational medicines through an AI-native drug discovery and development platform.

What you will do

  • Lead clinical pharmacology and pharmacometric strategies for rare disease and oncology clinical programs.
  • Provide clinical pharmacology input across Phase 1–3 studies and design dedicated clinical pharmacology studies.
  • Author clinical pharmacology sections for Investigator’s Brochures, INDs, NDAs, and other regulatory submissions.
  • Represent clinical pharmacology in interactions with regulatory health authorities.
  • Collaborate with clinical, translational, preclinical, DMPK, toxicology, biomarker, regulatory, and biostatistics teams.
  • Oversee or perform modeling and simulation to support dose selection, exposure-response, and exposure-safety decisions.

Requirements

  • Ph.D. in Pharmaceutical Sciences, Pharmacokinetics, or a related discipline; M.D. with clinical pharmacology expertise; or Pharm.D. with a clinical pharmacology fellowship.
  • 5–9+ years of experience in biotechnology or pharmaceutical drug development.
  • Demonstrated success leading clinical pharmacology aspects of drug development.
  • Experience with PK, PK-PD, and PK-safety analyses, including non-compartmental analysis, population PK modeling, and PK-PD modeling and simulations.
  • Proficiency with WinNonlin, Monolix, NONMEM, R, or other modeling software.
  • Experience responding to regulatory agency questions, preparing regulatory submissions, and attending regulatory meetings.

Nice to have

  • Oncology experience.

Culture & Benefits

  • Cross-functional collaboration across discovery and development sciences.
  • Values centered on integrity, ownership, direct communication, adaptability, and urgency for patients.
  • Remote work option with regular on-site visits for routine work and departmental events.
  • Annual bonus, equity compensation, and comprehensive benefits.
  • Equal opportunity workplace with accommodations available during the selection process.

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