2 дня назад
Associate Director, Clinical Supplies Project Manager (Clinical Supplies)
142 500 - 256 500$
Мэтч & Сопровод
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Описание вакансии
Текст:
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
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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