{"id":2199200,"url":"https://alion.io/job/celldex-associate-manager-expanded-access-program","title":"Associate Manager, Expanded Access Program","company":{"id":3786145,"name":"celldex","domain":"celldex.com","url":"https://alion.io/company/celldex","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"iCIMS","truth_index":null},"role":"Management","role_family":"Management","seniority":"junior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["New Haven, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":101005,"max":131175,"currency":"USD","period":"year","gross":null,"usd_annual":131175},"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-09T20:41:27Z","employer_posted_date":"2026-10-09","last_verified_at":"2026-10-12T04:04:17Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"Overview\nThe Associate 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.\nThe Associate 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.\nResponsibilities\nProgram Oversight\nServe as the operational lead in collaboration with the Executive Director for the global Expanded Access Program(s).\nLead with support from the Executive Director internal cross-functional alignment and reporting activities.\nProvide sponsor oversight of outsourced EAP vendors responsible for day-to-day case management and program execution.\nEnsure programs are conducted in compliance with applicable global regulations, GxP ,company SOPs, and internal governance.\nSupport the development and maintain operational plans supporting individual and programmatic expanded access initiatives.\nWork in collaboration with the Executive Director to ensure appropriate escalation pathways are established and utilized for operational risks and patient safety concerns.\nVendor Management\nAct as the primary contact for outsourced EAP vendors.\nMonitor vendor performance against established KPIs, SLAs, quality metrics, and timelines.\nLead routine governance meetings, operational reviews, and issue resolution discussions.\nReview vendor deliverables for quality and regulatory compliance.\nPartner with cross functional resources on contract execution, scope management, budgeting, and performance evaluations.\nOperational Excellence\nDevelop, implement, and continuously improve operational processes, SOPs, work instructions, and governance models.\nEstablish dashboards and metrics to monitor program health, vendor performance, patient access timelines, and operational risks.\nIdentify opportunities for process improvements, automation, and standardization.\nSupport inspection readiness activities and regulatory inspections involving expanded access activities.\nFinancial Management\nManage vendor budgets and forecasts with oversight from the Executive Director..\nReview invoices and ensure services align with contracted scope.\nIdentify opportunities for operational efficiencies and cost optimization.\nCompliance & Risk Management\nEnsure operational compliance with FDA Expanded Access regulations, EU Compassionate Use programs, Right-to-Try considerations where applicable, and other global regulatory requirements.\nMonitor emerging regulatory guidance impacting expanded access.\nEscalate operational, quality, compliance, or supply risks to leadership.\nSupport CAPA development and implementation when required.\nQualifications\nBachelor's degree in Life Sciences, Nursing, Pharmacy, or related scientific discipline required or equivalent education and experience\n3-5 years of biotechnology or pharmaceutical industry experience.\nMinimum 1-3 years in Clinical Operations, Development Operations, Medical Affairs Operations, or related operational role.\nExperience managing outsourced vendors and service providers.\nExperience supporting global clinical development programs.\nKnowledge of Expanded Access Programs, Compassionate Use, or Managed Access programs strongly preferred.\nExperience working within cross-functional matrix organizations.\nStrong understanding of drug development and clinical research operations.\nFamiliarity with FDA Expanded Access regulations (21 CFR Part 312), EMA Compassionate Use frameworks, and international regulatory requirements.\nDemonstrated vendor oversight and governance experience.\nExcellent project management and organizational skills.\nStrong analytical and operational problem-solving abilities.\nExcellent written and verbal communication skills.\nAbility to influence without direct authority in a matrix environment.\nStrong collaboration and relationship-building skills\nPatient-focused decision making\nEffective risk assessment and issue resolution\nCompensation Statement\nThe expected base salary for this position is: $101005.00 to $131175.00. 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.","description_format":"text","description_chars":5591,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Health Care","Professional Services"],"lifecycle":[{"event":"open","at":"2026-10-09T20:41:27Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":2,"expected_fill_days":17,"reasons":["conf:2","win:early","comp:junior"],"computed_at":"2026-10-12T06:55:09Z"},"pay":{"stated_usd_annual":131175,"is_top_pay":true},"html_url":"https://alion.io/job/celldex-associate-manager-expanded-access-program","json_url":"https://alion.io/job/celldex-associate-manager-expanded-access-program.json","meta":{"generated_at":"2026-10-12T07:27:14Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":11951,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-13T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":3786145},"rest":"https://alion.io/mcp/rest/get_company?id=3786145"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fcelldex-associate-manager-expanded-access-program"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fcelldex-associate-manager-expanded-access-program"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fcelldex-associate-manager-expanded-access-program"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/celldex-associate-manager-expanded-access-program\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fcelldex-associate-manager-expanded-access-program"}]}