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2 дня назад

Senior Manager, Clinical Supplies Project Manager (Biotech)

130 800 - 209 400$
Формат работы
hybrid
Тип работы
fulltime
Грейд
senior
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
Senior Manager, Clinical Supplies Project Manager (Biotech): Managing clinical drug supply planning, packaging, labeling, distribution, IRT, and vendor operations across clinical programs with an accent on cold-chain logistics, forecasting, inventory control, and regulatory compliance. Focus on coordinating international shipments, resolving supply issues, overseeing vendors, and aligning production schedules with clinical trial needs.

Location: Cambridge, Massachusetts, United States; 70% in-office work model.

Salary: $130,800–$209,400 per year, plus potential bonus, incentive compensation, or equity.

Company

hirify.global develops mRNA technology and medicines through a biopharmaceutical research and manufacturing platform.

What you will do

  • Manage clinical drug supply logistics, including cold-chain packaging, labeling, shipment, depot and investigative-site distribution, and international transit.
  • Plan and forecast clinical supply needs and align master production schedules with clinical trial requirements.
  • Define and manage IRT requirements, user acceptance testing, inventory control, and distribution activities.
  • Oversee third-party vendors, including procurement, packaging and labeling performance, delivery, quality, scope, and issue resolution.
  • Develop KPIs, processes, SOP-compliant workflows, pharmacy manuals, and training materials for investigative sites.
  • Collaborate with CMC, clinical, regulatory, functional leads, CROs, and therapeutic-area teams to meet program objectives.

Requirements

  • 5–8 years of experience in clinical drug supply management, clinical supply chain, or clinical supplies in a clinical research environment.
  • Bachelor’s degree in a science-based subject.
  • Required experience with cold-chain packaging, labeling, distribution, IRT design and management, clinical supplies planning and forecasting, and clinical supply inventory management systems.
  • Experience managing vendor relationships and participating in business review meetings.
  • Working knowledge of ICH, FDA, IRB/IEC, applicable regulations, and clinical research protocol requirements.
  • Proficiency with Microsoft Office tools, including Outlook, Word, Excel, PowerPoint, and SharePoint.

Nice to have

  • Biopharmaceutical, pharmaceutical, or chemical manufacturing experience.
  • Creative problem-solving skills and experience proposing improvements in clinical research operations.

Culture & Benefits

  • In-person collaboration supported through a 70/30 work model.
  • Healthcare 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 a year-end shutdown.
  • Savings and investment programs plus location-specific benefits.

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