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Open Access Program Coordinator

Manchester, NH · On-site

$60 - $80/hr

Open Access Program Coordinator Location : Manchester, NH Job Type : Full-time (40 hours/week) About Us Everyone deserves to feel healthy both body and mind. Here at The Mental Health Center, we're ...

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How much do expanded access program coordinator jobs pay per year?

As of Sep 9, 2026, the average yearly pay for expanded access program coordinator in the United States is $47,879.00, according to ZipRecruiter salary data. Most workers in this role earn between $40,000.00 and $53,500.00 per year, depending on experience, location, and employer.

What is an expanded access program coordinator?

An Expanded Access Program Coordinator is a professional responsible for managing and overseeing expanded access or compassionate use programs, which allow patients with serious or life-threatening conditions to access investigational drugs or treatments outside of clinical trials. They work closely with healthcare providers, regulatory agencies, and pharmaceutical companies to ensure compliance with regulations and to facilitate patient access to potentially life-saving therapies. Their duties often include handling documentation, coordinating applications, and monitoring patient outcomes. This role requires strong organizational skills, knowledge of regulatory requirements, and effective communication with multiple stakeholders.

What are the key skills and qualifications needed to thrive as an expanded access program coordinator?

To thrive as an Expanded Access Program Coordinator, you need a solid background in clinical research, regulatory compliance, and knowledge of investigational drug protocols, usually supported by a degree in life sciences or a related field. Familiarity with clinical trial management systems (CTMS), FDA regulations, and documentation tools like Electronic Data Capture (EDC) systems is essential. Strong organizational skills, attention to detail, and effective communication are vital soft skills for managing multiple stakeholders and complex processes. These competencies are important to ensure patient safety, regulatory adherence, and successful coordination of expanded access to investigational therapies.

What are some common challenges faced by expanded access program coordinators and how can they be managed?

Expanded Access Program Coordinators often navigate complex regulatory requirements while ensuring timely patient access to investigational therapies. One of the main challenges is balancing strict compliance with FDA and institutional protocols against the urgent needs of patients and physicians. Coordinators also manage communication across multiple stakeholders, including sponsors, clinicians, and regulatory bodies. Strong organizational skills, attention to detail, and proactive communication are essential to effectively address these challenges and support successful program implementation.

What is the difference between Expanded Access Program Coordinator vs Clinical Trial Coordinator?

AspectExpanded Access Program CoordinatorClinical Trial Coordinator
CredentialsTypically requires a bachelor's degree in health sciences or related field; certifications like RAC or CCRA are commonRequires a bachelor's degree in health sciences, nursing, or related field; certifications like CCRP are common
Work EnvironmentWorks in pharmaceutical or biotech companies, focusing on patient access programsWorks in research settings, hospitals, or clinical research organizations managing trial logistics
Industry UsageUsed in pharmaceutical companies to manage expanded access requestsUsed in clinical research to coordinate trial activities

The Expanded Access Program Coordinator focuses on facilitating access to investigational drugs outside clinical trials, while the Clinical Trial Coordinator manages the logistics of clinical research studies. Both roles require similar educational backgrounds and certifications but differ in their specific responsibilities and work environments.

Is an Expanded Access Program Coordinator an entry level position?

An Expanded Access Program Coordinator is typically an entry-level to mid-level role that involves managing patient access to investigational drugs, requiring strong organizational and communication skills. While some positions may prefer prior experience or certifications in clinical research, many roles are suitable for candidates with relevant educational backgrounds and a willingness to learn. Advancement often depends on experience, additional training, and familiarity with regulatory requirements.

What are popular job titles related to Expanded Access Program Coordinator jobs?

For Expanded Access Program Coordinator jobs, the most frequently searched job titles are:

Infographic showing various Expanded Access Program Coordinator job openings in the United States as of September 2026, with employment types broken down into 1% As Needed, 79% Full Time, 17% Part Time, and 3% Contract. Highlights an 94% Physical, 1% Hybrid, and 5% Remote job distribution, with an average salary of $47,879 per year, or $23 per hour.

Manager, Expanded Access Program

Hampton, NJ • On-site

Celldex Therapeutics
Biotechnology Research and Development • 201 - 500 employees
Learn more about Celldex Therapeuticsexternal

$116K - $150K/yr

Other

Medical, Retirement, PTO

Posted 29 days ago

Job description

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.

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