Senior Manager, REMS and Specialty Pharmacy Operations

Company introduction:

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 COMP360 psilocybin, a proprietary, investigational, synthetic psilocybin treatment under evaluation for treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD). COMP360 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 COMP360 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

Job overview :

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 COMP360 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.

Location: Remote on the East Coast, United States.

Reports to: Senior Director, REMS & Specialty Pharmacy Operations.

• Roles and Responsibilities
• (include but not limited to) :

REMS 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

Specialty Pharmacy Operations

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

Vendor Management

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 escalate 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

Cross-Functional Collaboration

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

Translate approved REMS requirements into executable workflows while maintaining alignment with established functional ownership, governance, and escalation pathways

Coordinate cross-functional activities required to support launch readiness, ongoing program operations, and operational enhancements

Participate in governance forums and provide updates on operational performance, risks, dependencies, and mitigation plans

Support change management activities resulting from regulatory updates, process improvements, vendor changes, or evolving business needs

Launch Readiness and Continuous Improvement

Support launch readiness planning and execution, including operational testing, training deployment, simulation exercises, process validation, and readiness assessments

Analyze operational data and stakeholder feedback to identify trends, process constraints, and improvement opportunities

Develop routine operational reports and dashboards to support performance monitoring and decision-making

Facilitate cross-functional review of trends, coordinate approved improvements, and track implementation of corrective or preventive actions

Contribute to scalable processes that support compliant operations and an effective treatment site and patient experience

Candidate Profile:

Experience

5-8 years of experience in pharmaceutical, biotechnology, specialty pharmacy, healthcare services, patient support services, market access, or a related healthcare industry

At least 2 years of experience supporting REMS programs, specialty pharmacy operations, patient services, access operations, trade and distribution operations, or other regulated healthcare programs

Experience managing operational projects and coordinating cross-functional stakeholders

Experience working with external vendors, service providers, specialty pharmacies, or healthcare partners

Preferred Qualifications

Advanced degree such as an MBA, MPH, PharmD, MS, or equivalent preferred

Experience supporting product launch, launch readiness, or commercialization activities

Experience developing or maintaining SOPs, training materials, operational workflows, and process documentation

Knowledge of pharmaceutical compliance requirements and healthcare operational processes

Knowledge & Skills

Working knowledge of FDA REMS programs and associated operational requirements

Understanding of specialty pharmacy, patient access, and limited distribution workflows

Strong project management, organizational, and prioritization skills, with the ability to manage multiple priorities and dependencies in a fast-paced environment

Strong analytical, problem-solving, and issue-resolution skills

Experience tracking metrics and developing operational reports

Excellent written and verbal communication skills

Proficiency with Microsoft Office applications and operational reporting tools

Compensation Description (annually):

Our compensation package for permanent hires includes base salary, discretionary bonus, and equity, alongside our comprehensive benefits offering.

Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.

【Base salary per annum】:

$160