Senior Manager, REMS and Specialty Pharmacy Operations
East Coast, United States; Jersey City, New Jersey Company introduction: Compass Pathways plc (Nasdaq: CMPS) is a biotechnology companydedicatedto 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 in the East Coast, United States. Reports toSenior Director, REMS & Specialty Pharmacy Operations.
Roles and Responsibilities:- (include but not limited to):REMS OperationsSupport 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 OperationsSupport 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
- 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.
These include f lexibility & generous time off, parental & reproductive support, health & medical, mental health & wellbeing and Financial health.
Equal opportunities:
Reasonable accommodation We are committed to building a workplace where everyone’s wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. UK applicants We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability. US applicants Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law.
Sponsorship:
Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. Data Privacy:
All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.
