Director, Commercial REMS Operations - Pharmaceutical

Alexion • Boston, MA

20h • Hybrid

About The Position

At Alexion, AstraZeneca Rare Disease, we are united by a mission to transform the lives of people affected by rare diseases. Here, your work has the potential to shape meaningful outcomes for patients while influencing how we deliver compliant, efficient, and scalable commercial support across complex therapeutic areas. We are seeking a Director of Commercial REMS Operations to lead key strategies and tactics supporting US Commercial activities related to Risk Evaluation and Mitigation Strategies (REMS) programs. This is a highly visible role where you will help drive the development, implementation, and ongoing management of REMS initiatives across US Commercial, ensuring alignment, operational excellence, and continued focus on patient safety.

Requirements

• 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.

Nice To Haves

• Master’s degree in business administration, Public Health, Data Science, Life Sciences, or a related field.
• Experience supporting launch products requiring REMS design, implementation, or commercialization readiness activities.
• Experience working in high-growth, rapidly evolving commercial organizations.
• Knowledge of commercial data ecosystems, data governance practices, and healthcare data management principles.
• Experience overseeing vendors responsible for data engineering, reporting, automation, or analytics solutions.
• Exposure to Snowflake, SQL, Python, R, or other data and analytics technologies.
• Experience working with commercial dashboards, reporting platforms, or advanced data visualization tools.
• Experience supporting REMS-related field communications, sales training initiatives, or commercial capability-building programs.
• Experience leading vendor governance, budget oversight, contract management, and performance review processes.

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.

Benefits

• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Director