Overview:
The Manager, Expanded Access Program (EAP) is responsible for the operational oversight and governance of the company's global Expanded Access Program portfolio. Reporting to Executive Director, Clinical Operations, this role serves as the primary representative responsible for overseeing outsourced EAP operations, ensuring vendor performance, regulatory compliance, cross-functional alignment, and an exceptional experience for physicians and patients requesting access to investigational products outside of clinical trials.
The Manager will partner closely with Clinical Development, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Supply Chain, Quality, Legal, and external service providers to ensure expanded access requests are evaluated, processed, and managed efficiently and compliantly across multiple regions. This individual will provide strategic oversight of the outsourced vendor(s), establish operational processes, monitor performance metrics, manage budgets, and drive continuous process improvement.
Responsibilities:
Program Oversight
- Serve as the operational lead for the global Expanded Access Program(s).
- Lead internal cross-functional alignment and reporting activities.
- Provide sponsor oversight of outsourced EAP vendors responsible for day-to-day case management and program execution.
- Ensure programs are conducted in compliance with applicable global regulations, GxP ,company SOPs, and internal governance.
- Develop and maintain operational plans supporting individual and programmatic expanded access initiatives.
- Ensure appropriate escalation pathways are established and utilized for operational risks and patient safety concerns.
Vendor Management
- Act as the primary contact for outsourced EAP vendors.
- Monitor vendor performance against established KPIs, SLAs, quality metrics, and timelines.
- Lead routine governance meetings, operational reviews, and issue resolution discussions.
- Review vendor deliverables for quality and regulatory compliance.
- Partner with cross functional resources on contract execution, scope management, budgeting, and performance evaluations.
Operational Excellence
- Develop, implement, and continuously improve operational processes, SOPs, work instructions, and governance models.
- Establish dashboards and metrics to monitor program health, vendor performance, patient access timelines, and operational risks.
- Identify opportunities for process improvements, automation, and standardization.
- Support inspection readiness activities and regulatory inspections involving expanded access activities.
Financial Management
- Manage vendor budgets and forecasts.
- Review invoices and ensure services align with contracted scope.
- Identify opportunities for operational efficiencies and cost optimization.
Compliance & Risk Management
- Ensure operational compliance with FDA Expanded Access regulations, EU Compassionate Use programs, Right-to-Try considerations where applicable, and other global regulatory requirements.
- Monitor emerging regulatory guidance impacting expanded access.
- Escalate operational, quality, compliance, or supply risks to leadership.
- Support CAPA development and implementation when required.
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.
- Experience working within cross-functional matrix organizations.
- Strong understanding of drug development and clinical research operations.
- Familiarity with FDA Expanded Access regulations (21 CFR Part 312), EMA Compassionate Use frameworks, and international regulatory requirements.
- Demonstrated vendor oversight and governance experience.
- Excellent project management and organizational skills.
- Strong analytical and operational problem-solving abilities.
- Experience developing operational metrics and dashboards.
- Excellent written and verbal communication skills.
- Ability to influence without direct authority in a matrix environment.
- Strong collaboration and relationship-building skills
- Patient-focused decision making
- Effective risk assessment and issue resolution
- Continuous improvement orientation
- Adaptability in a fast-paced biotechnology environment
- Sound judgment and integrity
Compensation Statement:
The expected base salary for this position is: $116156.00 to $150852.00. 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.