Celldex · 19 hours ago
Clinical Trial Supply Manager
Hampton, NJ
Full-time
Onsite
Senior Level
$116K/yr - $151K/yr
5+ years expCelldex is a company focused on clinical trial management, and they are seeking a Clinical Trial Supply Manager to support the outsourcing of product manufacturing and distribution of materials to clinical sites. The role involves managing Phase 2/3 clinical supplies, overseeing activities at commercial contractors, and ensuring compliance with regulatory standards.
BiotechnologyHealth CareOncologyPharmaceutical
Responsibilities
Manage the storage, distribution, and inventory tracking of bulk product, labeled product, co-medication inventory throughout the supply chain internally and at CMO’s in the most cost-effective manner and in compliance with cGMP’s
Manage the day-to-day fulfillment of drug shipment requests for all products under clinical development in a cost effective and cGMP compliant manner
Schedule and implement labeling, packaging, and quality release operations internally and with CMOs to ensure continuous clinical supply
Responsible for receiving reports on excursions or deviations that may occur during shipment, handling, and storage of drug products. Drive such investigations to resolution in collaboration with Quality, CMO and clinical sites and define and implement procedures to minimize future occurrences
Implement tracking systems to document the genealogy and detailed lot usage history of all drugs for each clinical trial
Working internally and with CMOs, manage the distribution and global depot locations with special considerations on import licenses and shipping lead times for country specific requirements
Arrange for cost effective return/destruction of all products no longer suitable for clinical use
Meet financial objectives by forecasting budget requirements; preparing project budgets; reviewing CMO proposals, issuing and scheduling expenditures; analyzing change in scope and reviewing invoices for accuracy
Schedule and implement labeling, packaging, and quality release operations with CMOs to ensure continuous clinical supply
Work with CMOs, to manage the distribution and global depot locations with special considerations on import licenses and shipping lead times for country specific requirements
Meet financial objectives by forecasting budget requirements; preparing project budgets; reviewing CMO proposals, issuing and scheduling expenditures; analyzing change in scope and reviewing invoices for accuracy
Qualification
Required
BA/BS degree, or equivalent work experience
5+ years' experience working in a Manufacturing or Pharmaceutical Environment, at least two to three years of which directly involve Clinical Supplies/Supply Chain, Clinical Operations, Quality, or CMC role in a Biotech, Pharmaceutical, or CRO company
Experience managing internal resources and external contractors/vendors
Demonstrated success in delivering projects on time with team satisfaction
Experienced in meeting facilitation
Ability to travel up to 10-20%
Ability to develop collaborative working relationships with physicians, expert consultants, and contracted vendors
Strong medical writing skills, takes ownership of document, organizes timeline, works with other co-authors, resolves discrepancies and edits to achieve consistency, and uses precise accurate language and grammar
Knowledge and experience in clinical development
Strong working knowledge of IRT systems such as, Signant and Suvoda
Ability to multitask to meet timelines under changing conditions
Excellent analytical and organizational skills
Strong written/verbal communication skills
The ability to work independently and as part of a team
Team player with demonstrated ability to prospectively identify issues and to influence key project decisions to achieve positive outcomes
Proficiency in MS Office software such as Project, Word, Excel, Outlook, Visio, and PowerPoint
Preferred
Involvement in labeling, packaging and distribution is preferred
Benefits
Annual discretionary bonus
Long term incentive
401(K) plan with employer contribution
Health care and other insurance benefits (for employee and family)
Paid holidays
Vacation
Sick days
Company
Celldex
Celldex is pioneering new horizons in immunology to deliver life-changing therapies.
51-200 employees
H1B Sponsorship
Celldex has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)
2022 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.54B2024-02-29Post Ipo Equity· $460.5M
2023-11-07Post Ipo Equity· $200.5M
2021-07-12Post Ipo Equity· $287.5M
Leadership Team
A
Anthony Marucci
President & CEO
Ronald A. Pepin
Senior Vice President and Chief Business Officer
Recent News
2025-11-16
Company data provided by crunchbase