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 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 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