Director, Clinical Supplies

Celldex Therapeutics•Hampton, NJ

3d•$176,659 - $229,427

About The Position

This position of Director, Clinical Supplies will oversee on-going and new clinical trial labeling, packaging and distribution by third party Clinical Service Providers (CSP) for the US and ROW. This position will act as the primary point of contact with the third-party Clinical Service Providers and budget management while adhering to Good Manufacturing and Clinical Practices, company policies and procedures. This individual shall support the Supply Chain Management and Clinical Operations departments providing uninterrupted clinical supplies for the on-going clinical trials.

Requirements

Bachelor’s or Master’s degree in Engineering, Biological Sciences or Business Management.
10 years’ experience in managing clinical study product supply.
3-5 years’ experience in managing third-party service providers.
Project Management Certification.
Interpersonal skills to effectively manage internal and external communications.
Knowledge and experience in clinical development and clinical trial planning.
Analyze inventory, forecasts and budget spreadsheets.
Team player with demonstrated ability to prospectively identify issues and to influence key project decisions to achieve positive outcomes.
Proficient in the use of IRT systems, MS Outlook, Word, Excel, Power Point, Project.

Responsibilities

Direct CSPs by providing forecasts, requesting quotations for clinical labeling, packaging and distribution operations.
Direct staff to ensure uninterrupted supply of clinical trial products and rescue medications.
Monitor depot and site inventories via the Interactive Response Technology (IRT) and revise supply strategies as needed.
Support of any deviations/investigations/complaints resulting from clinical trial packaging, shipping and temperature deviations.
Manage the Clinical Service Provider trial budgets and monitor performance.
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.
Liaise with the Clinical Operation team to adhere with the clinical trial protocols.
Support the Supply Chain Management department by providing drug product and placebo forecasts for ongoing and future clinical trials.