Hybrid Senior REMS & Specialty Pharmacy Ops Lead

Compass Pathways Inc.; New Jersey; Hybrid; USD 150,000 - 210,000; Full time

Job summary

Compass Pathways plc is seeking a Senior Manager to lead REMS and specialty pharmacy operations in the United States. Hybrid work from Jersey City HQ or remote on the East Coast, with cross-functional collaboration across Regulatory Affairs, Quality, and Commercial teams to translate REMS requirements into scalable workflows.

The role emphasizes program execution, vendor management, and continuous improvement in a highly regulated environment, supporting patient access and launch readiness

Qualifications

• 5-8 years in pharma/biotech or related healthcare industry.
• At least 2 years supporting REMS or specialty pharmacy operations.
• Experience managing cross-functional projects with vendors.
• Advanced degree preferred (MBA, MPH, PharmD, MS).

Responsibilities

• Support implementation and ongoing execution of REMS operational workflows, including site certification, user training, patient enrollment, treatment documentation, monitoring, and reporting.
• Coordinate onboarding, training, and operational readiness for specialty pharmacy partners.
• Partner with Regulatory Affairs, Quality, Pharmacovigilance, Compliance, Medical Affairs, Patient Engagement, Market Access, Trade & Distribution, and Commercial teams to support operational execution.
• Assist launch readiness planning and execution, including testing, training deployment, process validation, and readiness assessments.

Skills

Project management

Organizational skills

Prioritization

Cross-functional collaboration

Education

MBA or equivalent

Tools

Microsoft Office

Operational reporting tools

Job description

Compass Pathways plc is seeking a Senior Manager to lead REMS and specialty pharmacy operations in the United States. Hybrid work from Jersey City HQ or remote on the East Coast, with cross-functional collaboration across Regulatory Affairs, Quality, and Commercial teams to translate REMS requirements into scalable workflows.

The role emphasizes program execution, vendor management, and continuous improvement in a highly regulated environment, supporting patient access and launch readiness