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2 дня назад

Associate Director, Clinical Supplies Project Manager (Clinical Supplies)

142 500 - 256 500$
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

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TL;DR
Associate Director, Clinical Supplies Project Manager (Clinical Supplies): Leading end-to-end clinical supply management for programs and studies with an accent on demand planning, cold-chain distribution, IRT management, labeling, packaging, and vendor oversight. Focus on coordinating cross-functional production and distribution activities, solving supply and logistics issues, and ensuring clinical trial timelines and quality requirements are met.

Location: Cambridge, Massachusetts, United States; 70% in-office work model. Only U.S. persons who are citizens, permanent residents, asylees, or refugees are eligible due to U.S. export-control requirements.

Salary: $142,500–$256,500 per year, with potential discretionary bonus, incentive compensation, or equity.

Company

hirify.global develops mRNA-based therapeutics and vaccines through its mRNA science, delivery technology, and manufacturing platform.

What you will do

  • Lead clinical supply activities and end-to-end supply strategies for programs and clinical studies.
  • Plan and oversee demand forecasting, inventory control, cold-chain distribution, labeling, packaging, shipment, and site activation activities.
  • Manage IRT requirements, implementation, user acceptance testing, and post-go-live supply management.
  • Coordinate production schedules and supply needs with CMC, clinical, regulatory, project management, CROs, and clinical packaging organizations.
  • Oversee vendors, procurement, delivery performance, quality, scope, issue resolution, and business reviews.
  • Develop KPIs, pharmacy manuals, site training materials, and clinical supply processes based on industry best practices.

Requirements

  • At least 8 years of clinical supply management experience in a clinical research environment.
  • Bachelor’s degree in a science-based subject; an advanced degree is preferred.
  • Prior cold-chain distribution experience.
  • Experience with IRT implementation, design, and management.
  • Knowledge of ICH, FDA, IRB/IEC, applicable regulations, and clinical research protocol requirements.
  • Experience with vendor oversight, relationship management, and Microsoft Office applications.

Nice to have

  • Biopharmaceutical, pharmaceutical, or chemical manufacturing experience.
  • Experience coaching junior colleagues or leading direct reports.

Culture & Benefits

  • 70/30 work model emphasizing in-office collaboration, teamwork, innovation, and mentorship.
  • Healthcare coverage and voluntary benefit programs.
  • Fitness, mindfulness, and mental health resources.
  • Family planning benefits, including fertility, adoption, and surrogacy support.
  • Paid vacation, volunteer days, sabbatical, global recharge days, and year-end shutdown.
  • Savings and investment opportunities plus location-specific benefits.

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