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6 дней назад

Executive Director, Clinical Pharmacology/Pharmacometrics

287 980 - 346 060$
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
Executive Director, Clinical Pharmacology/Pharmacometrics (Clinical Development/Pharmacometrics): Leading clinical pharmacology and pharmacometric strategy and execution across rare disease and oncology programs with an accent on modeling and simulation, clinical study design, and regulatory submissions. Focus on solving drug development questions, guiding dose selection and exposure-response analyses, and coordinating cross-functional work with clinical, translational, preclinical, and regulatory teams.

Location: Remote, United States; periodic travel required.

Annual base salary: $287,980–$346,060 in New York City, Boston, and the San Francisco Bay Area; $261,800–$314,600 in Salt Lake City and other U.S. locations. Annual bonus, equity compensation, and benefits are also available.

Company

hirify.global is a clinical-stage TechBio company using AI, biology, chemistry, and clinical development to advance investigational medicines for oncology, rare disease, neuroscience, immunology, and other areas of unmet need.

What you will do

  • Lead clinical pharmacology and pharmacometric strategy and execution across clinical development programs.
  • Develop modeling and simulation strategies to support product development and accelerate decision-making.
  • Provide clinical pharmacology input into Phase 1–3 studies and dedicated clinical pharmacology studies.
  • Prepare clinical pharmacology sections for Investigator’s Brochures, INDs, NDAs, and other regulatory submissions.
  • Represent clinical pharmacology in regulatory interactions and meetings with health authorities.
  • Collaborate with clinical development, DMPK, translational modeling, toxicology, preclinical, and due diligence teams.

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.
  • 10+ years of experience in biotech or pharmaceutical drug development.
  • Experience leading clinical pharmacology aspects of drug development and managing PK, PK-PD, and PK-safety analyses.
  • Experience with non-compartmental analysis, population PK modeling, PK-PD modeling, and simulations for dose selection and exposure-response or exposure-safety analyses.
  • Proficiency with WinNonlin, Monolix, NONMEM, R, or other modeling software.
  • Experience preparing regulatory submissions, responding to agency questions, and attending regulatory meetings.

Nice to have

  • Experience in oncology.

Culture & Benefits

  • Remote work arrangement with periodic travel.
  • Annual bonus and equity compensation.
  • Comprehensive benefits package.
  • Cross-functional collaboration across discovery and development teams.
  • Values emphasize scientific integrity, ownership, adaptability, urgency, and direct collaboration.

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