Global Expanded Access Program Lead

Celldex Therapeutics, Inc.; Hampton (NJ); On-site; USD 116,000 - 151,000; Full time

Job summary

Celldex Therapeutics, Inc. in New Jersey seeks a Manager for the Expanded Access Program (EAP) to oversee global EAP portfolio operations and ensure regulatory compliance.

You will partner with Clinical Development, Medical Affairs, Regulatory Affairs, and external vendors to evaluate, process, and manage access requests across regions. The role requires coordinating budgets, KPIs, and governance, driving continuous process improvements, and ensuring patient and physician satisfaction in a

Qualifications

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related scientific discipline required or equivalent education and experience.
• 5-8 years of biotechnology or pharmaceutical industry experience.
• Minimum 3 years in Clinical Operations, Development Operations, Medical Affairs Operations, or related operational role.
• Experience managing outsourced vendors and service providers.
• Experience supporting global clinical development programs.
• Knowledge of Expanded Access Programs, Compassionate Use, or Managed Access programs strongly preferred.

Responsibilities

• Program Oversight: Serve as the operational lead for the global Expanded Access Program(s).
• Vendor Management: Act as the primary contact for outsourced EAP vendors and monitor KPIs and SLAs.
• Operational Excellence: Develop and improve SOPs, dashboards, and governance models.
• Financial Management: Manage vendor budgets and forecasts; review invoices.

Skills

Vendor oversight

Cross-functional collaboration

Regulatory compliance

Budget management

Project management

Education

Bachelor's degree in Life Sciences or related field

Job description

Celldex Therapeutics, Inc. in New Jersey seeks a Manager for the Expanded Access Program (EAP) to oversee global EAP portfolio operations and ensure regulatory compliance.

You will partner with Clinical Development, Medical Affairs, Regulatory Affairs, and external vendors to evaluate, process, and manage access requests across regions. The role requires coordinating budgets, KPIs, and governance, driving continuous process improvements, and ensuring patient and physician satisfaction in a