Description

Company 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. - Compass Pathways.

Job overview:

The Senior Director, REMS & Specialty Pharmacy Operations will lead the operational design and execution of the REMS program and specialty distribution model supporting the U.S. launch of COMP360.

This role is accountable for building a compliant, scalable, and integrated operating model that enables safe, appropriate, and timely patient access in a complex, site‑based and controlled distribution environment. Success in this role requires close collaboration across multiple internal teams and external partners to translate regulatory requirements into practical, real‑world execution and ensure REMS, product distribution, and site readiness operate as a seamless end‑to‑end system through launch and commercialization.

The ideal candidate is a hands‑on operator who thrives in ambiguity and can balance regulatory rigour with operational feasibility in a fast‑paced launch setting.

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 responsibilities
(Include but are not limited to):

REMS Program Design & Operationalization:
- Translate REMS regulatory requirements into operational workflows across site certification, patient enrolment, treatment documentation and monitoring
- Design scalable processes that align with both regulatory expectations and real-world site workflows
- Partner with regulatory and Medical to ensure fidelity to REMS requirements while enabling operational feasibility
- Comfortable working in ambiguous, fast-paced launch environment
Specialty Pharmacy Operations
- Oversee integration between distribution systems and REMS requirements
- Site-of-care logistics
- Operationalize distribution pathways
End-to-End Access & Logistics Integration
- Ensure 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 functions
Cross-functional Integration:
- Serve as primary REMS operational partner across Regulatory & Compliance, Pharmacovigilance, Quality, Patient Engagement, Market Access, and Commercial
- Drive alignment on clear roles, responsibilities, and handoffs across functions
- Excellent cross-functional collaboration and stakeholder management skills
Site and Field Engagement:
- Develop REMS-related processes and materials to support site onboarding and certification, training requirements, and documentation standards
- Partner with the Field Patient Access and Commercial teams to ensure REMS requirements are understood and executable at the site and patient levels
- Identify and address operational barriers to site adoption and compliance
Vendor and Technology Management:
- Lead management of REMS vendor and supporting technology platform/s
- Oversee system design, integration, and data flow across REMS, patient access, and distribution systems
- Ensure systems support accurate tracking, reporting, and audit readiness
Compliance, Monitoring & Inspection Readiness:
- Establish processes for REMS monitoring and reporting, deviation tracking and escalation, and audit and inspection readiness
- Partner with Compliance and Quality to ensure program operates within all regulatory requirements
- Ability to balance compliance rigor with operational feasibility
- Strong attention to detail with ability to manage complex workflows and systems
Launch Readiness & Continuous Improvement:
- Lead 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 updates

Candidate Profile:

Bachelor’s degree required; advanced degree (MBA, MPH, PharmD or equivalent) preferred
8-12 years of experience in pharmaceutical or biotech industry
Direct experience supporting REMS programs, specialty pharmacy, or access operations strongly preferred
Experience in operations, patient support, access, or compliance related roles
Familiarity with trade and distribution models (eg specialty distribution, controlled distribution, or buy-and-bill environments)
Patient-centric leader who integrates compassion with operational rigor
Strong financial acumen and experience managing budgets and external partners
Data-driven decision maker with expertise in KPI development and performance optimization
Soft Skills: Deep empathy, exceptional communication skills, and the ability to navigate sensitive topics with rigour and compassion

【For NYC】Compensation Description (annually):

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 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 USD

Benefits & Compensation:

For an overview of our benefits package and compensation information, please visit "Working at Compass".

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.

Senior Director, REMS & Specialty Pharmacy Operations

Description

Benefits & Compensation:

Equal opportunities:

Sponsorship:

Data Privacy:

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