Senior Director, REMS & Specialty Pharmacy Operations

TL;DR

Senior Director, REMS & Specialty Pharmacy Operations (Biotech): Lead end-to-end operational design and execution of REMS program and specialty distribution model for COMP360 launch in the US with an accent on regulatory compliance, scalable processes, and cross-functional integration. Focus on translating REMS requirements into site workflows, overseeing distribution logistics, and ensuring seamless patient access and site readiness.

Hybrid in our New York City office or remote on the east coast in the United States. Approximately 20-30% travel. Must have employment rights in the US; no visa sponsorship.

$240,000 - $300,000 USD

Company

Biotechnology company developing COMP360 psilocybin therapy for mental health conditions like treatment-resistant depression, PTSD, and anorexia nervosa, with Phase 3 trials ongoing.

What you will do

• Design and operationalize REMS program, translating regulatory requirements into scalable workflows for site certification, patient enrollment, and monitoring.
• Oversee specialty pharmacy operations, including distribution integration, site-of-care logistics, and product fulfillment pathways.
• Integrate end-to-end access and logistics, resolving breakdowns between patient support, distribution, and site operations.
• Drive cross-functional alignment with Regulatory, Pharmacovigilance, Quality, Commercial, and Market Access teams on roles and handoffs.
• Develop site onboarding materials, training, and processes; partner with field teams to address adoption barriers.
• Manage REMS vendors and technology platforms for system integration, data flow, tracking, and audit readiness.
• Establish compliance monitoring, deviation tracking, and launch readiness activities like process validation and mock audits.

Requirements

• Bachelor’s degree required; advanced degree (MBA, MPH, PharmD) preferred.
• 8-12 years in pharmaceutical or biotech industry, with direct experience in REMS programs, specialty pharmacy, or access operations.
• Experience in operations, patient support, access, or compliance; familiarity with trade and distribution models.
• Strong financial acumen, budget management, data-driven KPIs, and stakeholder collaboration skills.
• Patient-centric with empathy, rigorous communication, and ability to thrive in ambiguity.

Culture & Benefits

• Hybrid or east coast remote work with 20-30% travel.
• Competitive total compensation including base salary, discretionary bonuses, and equity.
• Comprehensive benefits package detailed on company careers page.
• Commitment to diversity, equality, and reasonable accommodations.
• Focus on employee wellbeing and thriving mental health environment.