Expanded Access Project Manager

Blackfield Associates; United States; Remote; USD 80,000 - 120,000; Full time

Job summary

Blackfield Associates is seeking an Expanded Access Project Manager for a remote role with a global pharmaceutical distributor. The successful candidate will lead U.S. Expanded Access Programs, ensuring alignment with operational teams and managing project timelines, while possessing a solid background in the pharmaceutical or biotech industry.

Qualifications

• Solid background in pharmaceutical, biotech, or CRO industry.
• Proven experience in client-facing project management roles.
• Strong knowledge of U.S. clinical trial regulations.

Responsibilities

• Act as the main point of contact for U.S. Expanded Access Programs.
• Monitor program performance against KPIs and manage updates.
• Identify and address risks in program execution.

Skills

Project Management

Client Communication

Organizational Skills

Time Management

Job description

Recruitment Consultant | Quality | MSAT | Tech Ops

Blackfield Associates is currently partnered with a global pharmaceutical distributor to support their search for an Expanded Access Project Manager to join their team on a remote basis.

Responsibilities:

1. Act as the main point of contact for U.S. Expanded Access Programs (EAP), leading meetings, managing project timelines, and maintaining consistent communication with clients and internal teams.
2. Collaborate with global EAP and U.S. operational teams to ensure alignment and readiness for program delivery.
3. Monitor program performance against KPIs and manage updates on patient and site activities.
4. Identify and address risks in program execution, providing timely resolutions.
5. Coordinate with regulatory contacts for non-U.S. programs to support documentation and supply chain clarity.
6. Maintain accurate forecasting and reporting of patient enrollments, shipments, and orders.

Required Experience:

• Solid background in the pharmaceutical, biotech, or CRO industry.
• Proven experience in client-facing project management roles.
• Strong knowledge of U.S. clinical trial regulations; familiarity with U.S. Expanded Access regulations is a plus.
• Skilled in external stakeholder communication and confident in leading discussions at all levels.
• Excellent organizational and time management skills.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Research and Project Management

Industries

• Pharmaceutical Manufacturing, Biotechnology Research, and Research Services

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