Head of Programme Management

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.

Provide sponsor oversight of outsourced EAP vendors responsible for day-to-day case management and program execution.Ensure appropriate escalation pathways are established and utilized for operational risks and patient safety concerns.Vendor ManagementAct as the primary contact for outsourced EAP vendors.Monitor vendor performance against established KPIs, SLAs, quality metrics, and timelines.Review vendor deliverables for quality and regulatory compliance.Partner with cross functional resources on contract execution, scope management, budgeting, and performance evaluations.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 ManagementManage vendor budgets and forecasts.Compliance & Risk ManagementEnsure 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.

Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related scientific discipline required or equivalent education and experience5-8 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.Knowledge of Expanded Access Programs, Compassionate Use, or Managed Access programs strongly preferred.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.Excellent project management and organizational skills.Strong collaboration and relationship-building skillsPatient-focused decision makingEffective risk assessment and issue resolutionContinuous improvement orientationAdaptability in a fast-paced biotechnology environmentSound judgment and integrity

Compensation for this role 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 pageCelldex 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.