Clinical Trial Supply Manager

Celldex Therapeutics•Hampton, NJ

8d•$116,156 - $150,852

About The Position

The Clinical Supplies Trial Manager will support outsourcing of product manufacturing including labeling, packaging, and distribution of materials to clinical sites in the US and ROW. The key responsibilities that the Clinical Supplies Trial Manager will perform are managing Phase 2/3 clinical supplies and clinical distribution for global studies and investigating overseeing activities at commercial labeling / distribution contractors.

Requirements

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
Involvement in labeling, packaging and distribution is preferred
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

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.