Senior Director, REMS & Specialty Pharmacy Operations
Compass Pathways, New York, NY, United States
Job Overview
The 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 United States.
This role will be responsible for translating regulatory REMS requirements and product distribution strategy into an integrated, scalable, compliant, and operationally efficient set of processes that enable treatment sites, patients, and internal teams to successfully navigate certification, enrollment, 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, protecting patient safety while streamlining processes to enable timely access to therapy.
The position reports to the VP, Patient Engagement and works 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 effectively bridges regulatory requirements with real‑world execution.
Location Hybrid in our New York City office or remote on the east coast of the United States. Approximately 20‑30% travel.
Reports to VP, Patient Engagement.
Roles And Responsibilities
REMS Program Design & Operationalization
Translate REMS regulatory requirements into operational workflows across site certification, patient enrollment, treatment documentation, and monitoring.
Design scalable processes that align with both regulatory expectations and real‑world site workflows.
Partner with regulatory and medical teams to ensure fidelity to REMS requirements while enabling operational feasibility.
Comfortable working in an ambiguous, fast‑paced launch environment.
Specialty Pharmacy Operations
Oversee integration between distribution systems and REMS requirements.
Manage site‑of‑care logistics and operationalize distribution pathways.
End‑to‑End Access & Logistics Integration
Ensure seamless coordination across REMS, product ordering and fulfillment, site scheduling readiness, and identify and resolve breakdowns between patient support, distribution, and site operations.
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 teams.
Drive alignment on clear roles, responsibilities, and hand‑offs 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 the program operates within all regulatory requirements.
Balance compliance rigor with operational feasibility.
Strong attention to detail with the 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.
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 the 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 (e.g., 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 rigor and compassion.
Benefits & Compensation Base pay is one part of the Total Package that compensates and recognizes employees for their work. The base salary range is $240,000—$300,000 USD per annum. Additional discretionary bonuses and equity may be provided.
Equal Opportunities Compass Pathways is 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, sexual orientation, gender identity, disability, or any other status protected by applicable law.
Reasonable Accommodation We are committed to building a workplace where everyone’s wellbeing matters. If you need reasonable accommodation during the interview process, please let our recruiting team know.
UK Applicants 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 in accordance with the Equality Act 2010.
US Applicants All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to any 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.
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This role will be responsible for translating regulatory REMS requirements and product distribution strategy into an integrated, scalable, compliant, and operationally efficient set of processes that enable treatment sites, patients, and internal teams to successfully navigate certification, enrollment, 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, protecting patient safety while streamlining processes to enable timely access to therapy.
The position reports to the VP, Patient Engagement and works 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 effectively bridges regulatory requirements with real‑world execution.
Location Hybrid in our New York City office or remote on the east coast of the United States. Approximately 20‑30% travel.
Reports to VP, Patient Engagement.
Roles And Responsibilities
REMS Program Design & Operationalization
Translate REMS regulatory requirements into operational workflows across site certification, patient enrollment, treatment documentation, and monitoring.
Design scalable processes that align with both regulatory expectations and real‑world site workflows.
Partner with regulatory and medical teams to ensure fidelity to REMS requirements while enabling operational feasibility.
Comfortable working in an ambiguous, fast‑paced launch environment.
Specialty Pharmacy Operations
Oversee integration between distribution systems and REMS requirements.
Manage site‑of‑care logistics and operationalize distribution pathways.
End‑to‑End Access & Logistics Integration
Ensure seamless coordination across REMS, product ordering and fulfillment, site scheduling readiness, and identify and resolve breakdowns between patient support, distribution, and site operations.
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 teams.
Drive alignment on clear roles, responsibilities, and hand‑offs 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 the program operates within all regulatory requirements.
Balance compliance rigor with operational feasibility.
Strong attention to detail with the 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.
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 the 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 (e.g., 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 rigor and compassion.
Benefits & Compensation Base pay is one part of the Total Package that compensates and recognizes employees for their work. The base salary range is $240,000—$300,000 USD per annum. Additional discretionary bonuses and equity may be provided.
Equal Opportunities Compass Pathways is 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, sexual orientation, gender identity, disability, or any other status protected by applicable law.
Reasonable Accommodation We are committed to building a workplace where everyone’s wellbeing matters. If you need reasonable accommodation during the interview process, please let our recruiting team know.
UK Applicants 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 in accordance with the Equality Act 2010.
US Applicants All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to any 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.
#J-18808-Ljbffr