Senior Director, REMS & Specialty Pharmacy Operations New York, United States

Senior Director, REMS & Specialty Pharmacy OperationsNew York, United StatesCompany introduction:Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments.We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area.We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive.Job overviewThe Senior Director, Risk Evaluation and Mitigation Strategy (REMS) & Specialty Pharmacy Operations will lead the end-to-end operational design and execution of the REMS program and specialty distribution model supporting the launch of COMP360 in the US.This role will be responsible for translating regulatory REMS requirements and product distribution strategy into an integrated, scalable, compliant, and operationally efficient processes that enable treatment sites, patients, and internal teams to successfully navigate certification, enrolment, access, and treatment workflows.Given the complexity of COMP360 – including site-based administration, controlled distribution, and structured monitoring requirements – this leader will play a critical role ensuring that REMS execution, product distribution, and site readiness operate as a seamless system and is implemented in a way that protects patient safety while streamlining processes to enable appropriate and timely access to therapy.This position will report to the VP, Patient Engagement and will work cross-functionally with Regulatory, Pharmacovigilance, Quality, Compliance, Medical Affairs, Trade & Distribution, Commercial, and Market Access teams.The ideal candidate is a strong operator who thrives in ambiguity, can build processes from the ground up, and can effectively bridge regulatory requirements with real-world execution.Location: Hybrid in our New York City office or remote on the east coast in the United States. Approximately 20-30% travel.Reports to: VP, Patient Engagement.Roles and responsibilitiesTranslate REMS regulatory requirements into operational workflows across site certification, patient enrolment, treatment documentation and monitoringDesign scalable processes that align with both regulatory expectations and real-world site workflowsPartner with regulatory and Medical to ensure fidelity to REMS requirements while enabling operational feasibilityComfortable working in ambiguous, fast-paced launch environmentSpecialty Pharmacy OperationsOversee integration between distribution systems and REMS requirementsSite-of-care logisticsOperationalize distribution pathwaysEnd-to-End Access & Logistics IntegrationEnsure seamless coordination across REMS, product ordering and fulfilment, site scheduling readiness, identify and resolve breakdowns between patient support, distribution, and site operations, and establish clear hand-offs between functionsCross-functional IntegrationServe as primary REMS operational partner across Regulatory & Compliance, Pharmacovigilance, Quality, Patient Engagement, Market Access, and CommercialDrive alignment on clear roles, responsibilities, and handoffs across functionsExcellent cross-functional collaboration and stakeholder management skillsSite and Field EngagementDevelop REMS-related processes and materials to support site onboarding and certification, training requirements, and documentation standardsPartner with the Field Patient Access and Commercial teams to ensure REMS requirements are understood and executable at the site and patient levelsIdentify and address operational barriers to site adoption and complianceVendor and Technology ManagementLead management of REMS vendor and supporting technology platform/sOversee system design, integration, and data flow across REMS, patient access, and distribution systemsEnsure systems support accurate tracking, reporting, and audit readinessCompliance, Monitoring & Inspection ReadinessEstablish processes for REMS monitoring and reporting, deviation tracking and escalation, and audit and inspection readinessPartner with Compliance and Quality to ensure program operates within all regulatory requirementsAbility to balance compliance rigor with operational feasibilityStrong attention to detail with ability to manage complex workflows and systemsLaunch Readiness & Continuous ImprovementLead REMS readiness activities for launch, including process validation, training completion, mock audits and simulations, and continuously assess program performance and implement improvements based on site feedback, field insights, and regulatory updatesCandidate Profile:Bachelor's degree required; advanced degree (MBA, MPH, PharmD or equivalent) preferred8-12 years of experience in pharmaceutical or biotech industryDirect experience supporting REMS programs, specialty pharmacy, or access operations strongly preferredExperience in operations, patient support, access, or compliance related rolesFamiliarity with trade and distribution models (eg specialty distribution, controlled distribution, or buy-and-bill environments)Patient-centric leader who integrates compassion with operational rigorStrong financial acumen and experience managing budgets and external partnersData-driven decision maker with expertise in KPI development and performance optimizationSoft Skills: Deep empathy, exceptional communication skills, and the ability to navigate sensitive topics with rigour and compassionPlease 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 pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity.Base salary per annum:$240,000 - $300,000 USDBenefits & Compensation:For an overview of our benefits package and compensation information, we refer you to our internal resources.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 applicantsWe 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 applicantsCompass 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.SponsorshipUnfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying.Data PrivacyAll 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.J-18808-Ljbffr