Director, Clinical Supplies

About the role

Celldex is looking for a Director, Clinical Supplies in Hampton, NJ, to oversee ongoing and new clinical trial labeling, packaging and distribution by third-party Clinical Service Providers (CSP) for the US and ROW. The role acts as the main contact with the CSPs, manages their budgets and ensures uninterrupted clinical supplies for ongoing trials while following Good Manufacturing and Clinical Practices and company policy.

Key responsibilities

• Direct CSPs by providing forecasts and requesting quotations for clinical labeling, packaging and distribution.
• Direct staff to ensure an uninterrupted supply of clinical trial products and rescue medications.
• Monitor depot and site inventories via the Interactive Response Technology (IRT) system and adjust supply strategies as needed.
• Support investigations and complaints arising from packaging, shipping and temperature deviations.
• Manage CSP trial budgets and monitor their performance.
• Forecast budget needs, prepare project budgets, review CMO proposals, schedule expenditures and check invoices for accuracy.
• Liaise with the Clinical Operations team to follow clinical trial protocols.
• Provide drug product and placebo forecasts to the Supply Chain Management department.

Required profile

• Bachelor's or Master's degree in Engineering, Biological Sciences or Business Management.
• 10 years of experience managing clinical study product supply.
• 3-5 years of experience managing third-party service providers.
• Project Management certification.
• Knowledge of clinical development and clinical trial planning.
• Ability to analyze inventory, forecast and budget spreadsheets.

Required skills

• IRT systems
• MS Outlook, Word, Excel, PowerPoint and Project
• Strong communication skills with internal and external stakeholders

What we offer

• Expected base salary of $176,659 to $229,427.
• Annual discretionary bonus and long-term incentive.
• 401(k) plan with employer contribution.
• Health care and other insurance benefits for employee and family.
• Paid holidays, vacation and sick days.