Global Expanded Access Operations Lead

Celldex; New Haven (CT); On-site; USD 116,000 - 151,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

401(k) with employer contribution

Health insurance and other benefits

Paid holidays

Job summary

Celldex in New Haven, CT, is seeking a Manager, Expanded Access Program (EAP) to oversee global EAP portfolio operations and outsourced vendors, ensuring regulatory compliance and a high-quality experience for physicians and patients seeking investigational products outside trials.

You will partner with Clinical Development, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Supply Chain, Quality, Legal, and external providers to evaluate, process, and manage expanded access requests

Qualifications

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related field.
• 5–8 years of biotechnology or pharmaceutical industry experience.
• Minimum 3 years in Clinical 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 is preferred.
• Experience in matrix, cross-functional organizations.
• Understanding of drug development and clinical research operations.
• Familiarity with FDA Expanded Access regulations (21 CFR Part 312) and EMA frameworks.

Responsibilities

• Provide operational oversight for global Expanded Access Programs.
• Lead cross-functional alignment and reporting.
• Oversee outsourced EAP vendors for case management and program execution.
• Ensure compliance with global regulations, SOPs, and governance.
• Develop and maintain operational plans for expanded access initiatives.
• Establish escalation pathways for risks and patient safety.

Skills

Communication skills

Analytical skills

Influence without authority

Collaboration

Patient-focused decisions

Adaptability

Education

Bachelor's degree in Life Sciences, Nursing, Pharmacy or related field

Job description

Celldex in New Haven, CT, is seeking a Manager, Expanded Access Program (EAP) to oversee global EAP portfolio operations and outsourced vendors, ensuring regulatory compliance and a high-quality experience for physicians and patients seeking investigational products outside trials.

You will partner with Clinical Development, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Supply Chain, Quality, Legal, and external providers to evaluate, process, and manage expanded access requests