Senior Manager, REMS and Specialty Pharmacy Operations

Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to unlocking urgently needed new treatment options in mental health care.

The Company is headquartered in London, UK, with a U.S. office in New Jersey. We believe mental health patients deserve the possibility of a better future. Our initial focus is developing COMP
360 psilocybin, a proprietary, investigational, synthetic psilocybin treatment under evaluation for treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD). COMP
360 is a potentially first-in-class treatment and has Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA), as well as Innovative Licensing and Access Pathway (ILAP) designation in the UK for TRD. We are leading the world’s largest classic psychedelic clinical program in TRD, and building upon that robust foundation, we are executing a late-stage trial evaluating COMP
360 for PTSD, another condition with high unmet need. Our goal is to advance treatments that move the field of psychiatry towards treatment options that offer rapid onset and sustained durability with infrequent dosing.

- Compass Pathways

The Senior Manager, REMS & Specialty Pharmacy Operations will support the implementation, execution, and ongoing optimization of the REMS program and specialty pharmacy operational model for COMP
360 in the United States. Partnering closely with the Senior Director, this role will help translate approved regulatory requirements and business objectives into compliant, scalable, and patient-centered operational processes.

This individual will oversee day-to-day REMS and specialty pharmacy operations, support vendor management and operational readiness activities, monitor program performance, and collaborate cross-functionally to ensure successful execution of approved REMS and distribution strategies. The ideal candidate brings experience in REMS, specialty pharmacy, patient services, or related pharmaceutical operations and thrives in a highly regulated environment.

Remote in the East Coast, United States.

Senior Director, REMS & Specialty Pharmacy Operations.

• Support implementation and ongoing execution of REMS operational workflows, including site certification, user training, patient enrollment, treatment documentation, monitoring, and reporting
• Coordinate operational activities required to support REMS compliance and consistent execution across certified treatment sites and operational partners
• Maintain REMS process documentation, standard operating procedures, training materials, job aids, and operational workflows
• Monitor REMS performance metrics, reports, deviations, exceptions, and potential noncompliance indicators; coordinate intake, documentation, triage, and escalation in accordance with approved procedures
• Support audit and inspection readiness activities, including documentation management, operational simulations, and response preparation

• Support implementation and ongoing management of specialty pharmacy operational workflows and distribution processes
• Coordinate onboarding, training, and operational readiness activities for specialty pharmacy partners
• Monitor specialty pharmacy performance metrics, service levels, turnaround times, and operational compliance indicators
• Partner with specialty pharmacy stakeholders to identify, troubleshoot, and resolve operational issues affecting treatment sites, healthcare providers, or patients
• Support execution of distribution-related process improvements and operational initiatives

• Serve as a primary day-to-day operational contact for the REMS Administrator, REMS operational vendors, and specialty pharmacy partners
• Track vendor deliverables, action items, performance metrics, service-level commitments, risks, and dependencies
• Support recurring business reviews and operational governance meetings with vendor partners
• Coordinate follow-up and resolution of vendor-related issues and elevate operational risks, compliance concerns, or unresolved matters to appropriate stakeholders and leadership
• Partner with Quality on vendor qualification, quality agreements, and supplier quality oversight activities, as applicable

• Partner with Regulatory Affairs, Quality, Pharmacovigilance, Compliance, Medical Affairs, Patient Engagement, Market Access, Trade & Distribution, and Commercial teams to…