Expanded Access & Post-Trial Ops Lead (Oncology)

Remote Worker LTD.; United States; Remote; USD 110,000 - 160,000; Full time

Job summary

Thermo Fisher Scientific is seeking an Expanded Access Manager / Post-Trial Access Specialist (Oncology) to provide operational leadership for managed access programs, including compassionate use, expanded access and post-trial access.

The role involves building strong cross-functional relationships across clinical operations, medical affairs, supply, and governance, ensuring effective communication with healthcare professionals, vendors, and external stakeholders.

Qualifications

• 3+ years in pharma/biotech/clinical research or CRO.
• Direct experience in clinical research or managed access.
• Oncology experience preferred.

Responsibilities

• Set up and manage operational support for post-trial managed access programs from planning through close-out, including budget coordination and vendor communications.
• Collaborate with clinical study teams to assess feasibility, regulatory requirements, and supply mechanisms for post-trial access.
• Partner with medical affairs, clinical operations and cross-functional stakeholders to deliver post-trial programs.
• Provide day-to-day coordination to support continuity of access for post-trial patients.
• Coordinate program status tracking, document management and data review in line with regulatory requirements.
• Manage vendors supporting program execution.
• Coordinate expanded access activities, including documentation and archiving, and track timelines and metrics.
• Provide regular program status and utilization updates to stakeholders.
• Collaborate with CMC and other areas to support clinical supply planning and forecasting.
• Develop project materials and tools for effective operationalization and communication.
• Identify delivery issues and coordinate corrective actions when deviations occur.
• Track milestones and contribute to program initiatives and process improvements.

Skills

Cross-functional collaboration

Project management

Attention to detail

Communication skills

Problem solving

Time management

Education

Bachelor’s degree in scientific/clinical discipline

Job description

Thermo Fisher Scientific is seeking an Expanded Access Manager / Post-Trial Access Specialist (Oncology) to provide operational leadership for managed access programs, including compassionate use, expanded access and post-trial access.

The role involves building strong cross-functional relationships across clinical operations, medical affairs, supply, and governance, ensuring effective communication with healthcare professionals, vendors, and external stakeholders.