Director, REMS Strategy & Commercial Operations

Alexion Pharmaceuticals, Inc.; Boston (MA); Hybrid; USD 216,000 - 260,000; Full time

Job summary

Alexion Pharmaceuticals, Inc. seeks a Director of Commercial REMS Operations to lead REMS strategy and execution for US Commercial activities across the rare disease portfolio.

You will partner with Commercial, Regulatory, Safety, IT, and external vendors to ensure REMS requirements support compliance and business success. The role requires strong leadership, deep REMS knowledge, and a track record of delivering scalable, data-driven programs in a complex matrix environment.

Qualifications

• Bachelor’s degree in Business, Life Sciences, Computer Science, Information Systems, Data Science, Engineering, Mathematics, or a related discipline.
• 7+ years of experience supporting REMS programs within the pharmaceutical or biotechnology industry.
• Demonstrated commercial experience supporting a product with an active FDA REMS program.
• Experience partnering directly with cross-functional Commercial leadership, Sales Operations, Field Enablement, Commercial Excellence, Patient Services, Market Access, Analytics, and Medical Affairs teams.
• Proven experience leading REMS strategy, operational execution, and cross-functional governance within a complex matrix environment.
• Strong understanding of FDA REMS requirements, compliance obligations, assessment activities, and ongoing program optimization.
• Experience translating regulatory requirements into effective commercial processes, field education strategies, and operational solutions.
• Advanced analytical capabilities with experience leveraging data to evaluate REMS effectiveness, identify business risks, inform decision-making, and drive continuous improvement.
• Experience managing external vendors and holding third-party partners accountable for operational execution, performance metrics, and compliance standards.
• Strong leadership, stakeholder management, and executive communication skills with the ability to influence across multiple functions and organizational levels.
• Demonstrated success managing multiple strategic initiatives simultaneously while delivering measurable business outcomes.

Responsibilities

• Lead Commercial REMS strategy, operational execution, governance, and performance across products and indications.
• Partner with field teams, sales operations, commercial enablement, and patient services organizations to strengthen REMS education, awareness, and execution.
• Translate REMS requirements into scalable business processes, field capabilities, communications, and training strategies.
• Drive data-informed decision making through reporting, analytics, performance monitoring, and business insights.
• Serve as the Commercial lead for REMS data strategy, governance, quality, and reporting.
• Lead cross-functional initiatives that improve REMS effectiveness, compliance, stakeholder experience, and operational efficiency.
• Oversee vendors supporting REMS operations, analytics, technology, and reporting solutions.
• Support launch readiness, new REMS initiatives, and ongoing program optimization.
• Present risks, opportunities, and strategic recommendations to senior leadership.

Skills

Leadership

Stakeholder management

Executive communication

Data analytics

Cross-functional teams

Vendor management

Regulatory knowledge

Strategic thinking

Education

Bachelor’s degree

Master’s degree (preferred)

Tools

Snowflake

SQL

Python

R

Data visualization tools

Job description

Alexion Pharmaceuticals, Inc. seeks a Director of Commercial REMS Operations to lead REMS strategy and execution for US Commercial activities across the rare disease portfolio.

You will partner with Commercial, Regulatory, Safety, IT, and external vendors to ensure REMS requirements support compliance and business success. The role requires strong leadership, deep REMS knowledge, and a track record of delivering scalable, data-driven programs in a complex matrix environment.