Director, Treatment Strategy & Operations

Role Summary

The Director, Treatment Experience Strategy & Operations is responsible for the development and execution of strategic initiatives that enhance patient access and owns strategic leadership of REMS and REMS‑adjacent patient services, integrating regulatory requirements with patient‑centric operational design. This is a great opportunity to grow and develop in a fast, entrepreneurial collaborative environment, and help move the needle with a rapidly growing company.

This position will report to the Head of Treatment Experience.

• Align patient services initiatives with REMS requirements, organizational goals, compliance standards, and market access strategies.
• Manage REMS compliance, audit readiness, and reporting. Oversee identification, tracking, and remediation of REMS‑related deviations and CAPAs, partnering with the REMS Compliance Team (RTC) to ensure corrective actions are appropriately scoped, implemented, and closed in a timely manner.
• Lead end‑to‑end REMS program strategy and operations, ensuring regulatory compliance while optimizing patient access, provider experience, and program effectiveness. Oversee REMS operational workflows, audit readiness, and reporting; support launches, updates, and lifecycle management of REMS programs.
• Lead the operational data gathering, analysis, and narrative development for REMS Assessment reports, coordinating with the REMS Compliance Team (RTC) for final regulatory, compliance/legal, drug safety, and quality review and approval prior to FDA submission.
• Serve as the operational lead interfacing with the RTC on REMS program matters, ensuring that strategic and operational decisions are informed by regulatory, compliance, drug safety, and quality input. Prepare materials and operational updates for RTC review meetings.
• Lead the operational impact assessment and implementation planning for REMS modifications, routing proposed changes through the RTC for regulatory and compliance approval before execution.
• Oversee the REMS portal platform, including system enhancements, user experience optimization for HCPs and patients, and coordination with technology vendors on build, maintenance, and validation activities.
• Develop and oversee REMS training programs and materials for internal teams, field sales, HCPs, and pharmacy partners, with RTC input on regulatory and compliance content accuracy.
• Provide oversight of the Treatment Experience budget and forecast.
• Drive digital‑first strategies for patient engagement and identify and implement technology solutions to streamline processes and enhance patient experience.
• Manage vendor relationships to deliver high quality services and operational excellence for both providers and patients.
• Define and refine key performance metrics by leveraging patient analytics, customer feedback, benchmarking, and compliance monitoring to drive continuous improvement in program outcomes, including KPI achievement, operational efficiency, and cycle time reduction.
• Demonstrate a comprehensive understanding of the patient and provider journey, and identify potential barriers to their onboarding experience.
• Collaborate and work cross‑functionally with all external vendors and internal stakeholders (i.e. Sales, Marketing, Market Access, Trade, Compliance, Commercial Operations, Legal, Drug Safety, Regulatory, and Quality) to support impactful strategies.

• Required:
  
  Bachelor’s Degree
• Preferred:
  Advanced Degree (Pharm‑D or Master’s Degree)
• Required:
  
  10‑12+ years of relevant working experience in Patient Services, REMS, Drug Safety/Pharmacovigilance, or GxP‑regulated operations within the pharmaceutical or biotechnology industry
• Preferred:
  Direct REMS program experience; candidates with deep GxP compliance backgrounds who can apply regulated‑operations expertise to REMS program management
• Required:
  
  Proven experience in strategic planning, project management and optimizing organizational effectiveness
• Preferred:
  Strategic thinker with ability to connect dots, prioritize, and influence through storytelling
• Required:
  
  Track record of successfully managing and leading vendor relationships from both a strategic and operational…