Director, Clinical Supplies

Celldex Therapeutics, Inc.; Hampton (NJ); On-site; USD 177,000 - 229,000; Full time

Benefits offered by this job

Annual discretionary bonus

Long term incentive

401(k) with employer contribution

Health insurance

Paid holidays

Vacation

Sick days

Job summary

Celldex Therapeutics, Inc. seeks a Director of Clinical Supplies to oversee labeling, packaging and distribution by CSPs for the US and ROW, acting as the primary liaison and ensuring GMP compliance.

This role supports Clinical Operations and Supply Chain Management to provide uninterrupted clinical supplies for ongoing trials. You will manage forecasts, budgets and invoices, collaborating with cross-functional teams to meet financial objectives and maintain supply continuity across current and

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.
• Knowledge of clinical development and clinical trial planning.
• Analyze inventory, forecasts and budget spreadsheets.
• Team player with demonstrated ability to identify issues and influence decisions.
• Proficient in IRT systems and MS Office tools.

Responsibilities

• Direct CSPs by providing forecasts and 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 deviations.
• Manage CSP budgets and monitor performance; forecast budget requirements and review invoices.
• Liaise with Clinical Operations to adhere to trial protocols.
• Support supply chain by providing drug product and placebo forecasts for trials.

Skills

Interpersonal skills

Team player

Budget forecasting

Communication

Clinical development knowledge

Education

Project Management Certification

Tools

Outlook

Word

Excel

PowerPoint

Microsoft 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.