Manager, Expanded Access Program

Overview In this role you oversee Celldex’s global Expanded Access Program portfolio, ensuring program governance, regulatory compliance, and strategic vendor management. You will coordinate cross-functional partners to evaluate and process access requests for investigational products outside trials, while driving performance and continuous improvement. You’ll lead outsourced EAP operations, balance budgets, and maintain readiness for inspections, all aimed at delivering timely, compliant patient access at scale. This position offers impact in shaping access programs within a fast-paced biotech environment. Compensation / Benefitsbase salaryannual discretionary bonuslong term incentive401(K) plan with employer contributionhealth care for employee and familypaid holidays, vacation, and sick days ResponsibilitiesOperational lead for global Expanded Access Programs and cross-functional alignmentSponsor oversight of outsourced EAP vendors and governance meetingsEnsure compliance with FDA/EMA/global regulations, GxP, and SOPsDevelop operational plans and escalation pathways for risk and patient safetyMonitor vendor performance against KPIs/SLAs and review deliverablesContract scoping, budgeting, and performance evaluations with cross-functional teamsDevelop, implement, and continuously improve SOPs, dashboards, and governance modelsSupport inspection readiness and regulatory inspections for EAP activitiesManage vendor budgets, forecasts, and cost optimization effortsEscalate operational, quality, or supply risks to leadership, and support CAPA as needed Key requirementsBachelor's degree in Life Sciences, Nursing, Pharmacy, or related discipline; 5–8 years in biotech/pharmaMinimum 3 years in clinical/operations or related operational roleExperience managing outsourced vendors and global programsKnowledge of Expanded Access, Compassionate Use, or Managed Access programs preferredStrong project management and organizational skills; ability to influence in matrix environmentsFamiliarity with FDA Expanded Access regulations (21 CFR Part 312) and EMA frameworks; regulatory knowledgeDemonstrated vendor oversight and governance experienceExcellent written and verbal communication skills; ability to develop operational metrics and dashboardscollaborationcommunicationinfluence without authorityvendor management and governanceoperational metrics and dashboardsregulatory compliance oversight (FDA/EMA)