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Salary: USD 160,000 - 190,000 / annual
COMPASS Pathways is a biotechnology company developing COMP360, a proprietary synthetic psilocybin treatment under investigation for treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD). The company holds FDA Breakthrough Therapy designation and is executing the world's largest classic psychedelic clinical program.
The Senior Manager, REMS and Specialty Pharmacy Operations will report to the Senior Director and oversee day-to-day execution of the Risk Evaluation and Mitigation Strategy (REMS) program and specialty pharmacy operational model for COMP360 in the United States. This role bridges regulatory requirements and business objectives into compliant, scalable, patient-centered processes.
Key responsibilities include:
**REMS Operations:** Support implementation and ongoing execution of REMS workflows including site certification, user training, patient enrollment, treatment documentation, monitoring, and reporting. Maintain REMS process documentation, standard operating procedures, training materials, and operational workflows. Monitor REMS performance metrics, deviations, exceptions, and noncompliance indicators; coordinate intake, documentation, triage, and escalation. Support audit and inspection readiness activities.
**Specialty Pharmacy Operations:** Support implementation and management of specialty pharmacy workflows and distribution processes. Coordinate onboarding, training, and operational readiness for specialty pharmacy partners. Monitor performance metrics, service levels, turnaround times, and compliance indicators. Troubleshoot and resolve operational issues affecting treatment sites, providers, or patients. Support distribution-related process improvements.
**Vendor Management:** Serve as primary day-to-day operational contact for REMS Administrator, operational vendors, and specialty pharmacy partners. Track vendor deliverables, action items, performance metrics, and service-level commitments. Support recurring business reviews and governance meetings. Coordinate resolution of vendor issues and escalate risks or compliance concerns.
**Cross-Functional Collaboration:** Partner with Regulatory Affairs, Quality, Pharmacovigilance, Compliance, Medical Affairs, Patient Engagement, Market Access, and Commercial teams. Translate approved REMS requirements into executable workflows. Coordinate launch readiness and operational enhancements. Participate in governance forums and support change management.
**Launch Readiness and Continuous Improvement:** Support launch readiness planning including operational testing, training deployment, simulations, and readiness assessments. Analyze operational data and stakeholder feedback to identify trends and improvement opportunities. Develop operational reports and dashboards. Facilitate cross-functional review and track implementation of corrective or preventive actions.
**Requirements:**
- 5–8 years of experience in pharmaceutical, biotechnology, specialty pharmacy, healthcare services, patient support services, market access, or related regulated healthcare operations
- Demonstrated experience with REMS programs, specialty pharmacy operations, or pharmaceutical distribution and compliance
- Strong knowledge of pharmaceutical regulatory requirements, compliance frameworks, and quality standards in a regulated environment
- Experience with vendor management, operational governance, and cross-functional collaboration in complex healthcare or pharmaceutical settings
- Excellent organizational, project management, and problem-solving skills
- Strong written and verbal communication skills
- Proficiency with Microsoft Office applications and operational reporting tools
