Director, Clinical Supplies

Celldex Therapeutics, Inc.; Hampton, Northern (VA, KY); Hybrid; USD 177,000 - 229,000; Full time

Benefits offered by this job

401(k) plan

Health insurance

Paid holidays

Vacation

Sick days

Equal opportunity employer

Job summary

Celldex Therapeutics, Inc. in United States (Hampton, VA area) seeks a Director, Clinical Supplies to oversee clinical labeling, packaging and distribution by third-party CSPs for the US and ROW.

This role acts as the primary point of contact with CSPs and budgets while ensuring GMP and clinical practices compliance. The position supports Supply Chain Management and Clinical Operations, ensuring uninterrupted clinical supplies for ongoing trials.

Qualifications

• 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 influence key decisions.
• Proficient in IRT systems, MS Outlook, Word, Excel, Power Point, Project.

Responsibilities

• Direct CSPs by providing forecasts and requesting quotations for labeling, packaging and distribution.
• Direct staff to ensure uninterrupted supply of clinical trial products and rescue medications.
• Monitor depot and site inventories via IRT and revise supply strategies as needed.
• Support deviations/investigations/complaints from packaging, shipping and temperature events.
• Manage CSP trial budgets and monitor performance.
• Forecast budget requirements, prepare project budgets, review proposals and invoices.
• Liaise with Clinical Operations to adhere to trial protocols.
• Provide drug product and placebo forecasts for ongoing and future trials.

Skills

Project management

Interpersonal skills

Team player

Budget forecasting

Inventory analysis

Supply chain coordination

Analytical thinking

Education

Bachelor’s or Master’s degree in Engineering, Biological Sciences or Business Management

Tools

IRT systems

MS Outlook

Word

Excel

PowerPoint

Project

Job description

Overview

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.

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.

Qualifications

• 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.

Compensation Statement

The expected base salary for this position is: $176659.00 to $229427.00. We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market. Subject to eligibility and applicable plan terms, compensation includes base salary, 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, and sick days. A summary of our benefits can be found on our careers page Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.