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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

US based EAP Program Manager


Reference:SCAMRX-138570 Location: Outside EU
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Medical Advisor, Medical Science Liaison

US based EAP Program Manager
Our client are currently recruiting for a US Expanded Access Program Manager to join their team on a permanent basis. In this role, you will lead all US-domestic Expanded Access Programs (EAPs) and co-manage global programs where US-specific program management and regulatory alignment are required. This is a remote role and you must be based in the US.

Responsibilities

  • Client Liaison: Serve as the lead point of contact for clients with US domestic Expanded Access projects. Organize and host weekly client meetings, drive project planning, and manage ongoing internal and external communications.
  • Global Collaboration: Partner closely with the global EAP team to ensure cross-functional program alignment and streamlined client communications.
  • Performance Oversight: Oversee program delivery, tracking progress closely against established KPI metrics.
  • Operational Setup: Collaborate with US operational and logistics teams to ensure all operating functions are set up for seamless delivery as new programs go live.
  • Site & Patient Registration: Manage day-to-day interactions with client teams to provide operational updates and discuss site and patient registrations.
  • Risk Mitigation: Proactively identify risks within the program delivery model and work collaboratively with internal and client teams to find swift resolutions.
  • Regulatory & Supply Chain Alignment: Develop strong working relationships with regulatory stakeholders for international programs to build a clear understanding of supply chain flows and documentation requirements.
  • Forecasting & Reporting: Track, report, and forecast patient enrolments, orders, and shipments to ensure continuous drug supply.
  • Communication: Deliver exceptional written and verbal communication, with demonstrated confidence in presenting to senior external stakeholders.
Requirements
Essential Experience & Skills:
  • Industry Experience: 3–5 years of experience within the Pharmaceutical, Biotech, or CRO sectors.
  • Client Management: At least 3 years of experience in an external, client-facing project or program management role.
  • Regulatory Knowledge: A solid working knowledge of US Clinical Trial legislation; direct working knowledge of US Expanded Access regulations (e.g., FDA Expanded Access pathways) is a distinct advantage.
  • Leadership: Highly confident leading discussions with stakeholders at all levels, from clinical site staff to pharmaceutical executives.
  • Organization: Exceptional organizational skills with a proven ability to prioritize multiple high-urgency tasks and meet tight deadlines.
  • Education: Educated to degree level (or equivalent) in a life sciences discipline.
Desirable:
  • Prior experience working on global Expanded Access Programs (e.g., Early Access, Compassionate Use, Named Patient Supply).
  • Direct experience with regulations governing clinical trials and patient data collection (e.g., GDPR, HIPAA).

For more information, please contact Sinéad Cullen on +353879500821 or [email protected]