Director, Commercial REMS Operations - Pharmaceutical

Director, Commercial REMS Operations

Alexion, AstraZeneca Rare Disease
Location:        Boston, MA (Seaport) preferred

alternate: New Haven, CT
 

Do you have expertise in REMS strategy, operations, and cross-functional commercial collaboration?

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.

What You'll Do

As Director, Commercial REMS Operations, you will lead the commercial strategy, execution, and continuous improvement of REMS programs across Alexion and AstraZeneca's rare disease portfolio. Serving as the primary Commercial REMS leader, you will partner with Commercial, Sales Operations, Commercial Enablement, Patient Services, Regulatory, Safety, Ethics & Compliance, IT, and external vendors to ensure REMS requirements support both compliance and business success. You will be accountable for Commercial REMS strategy and execution, serving as the primary REMS leader until escalation to the Senior Director.

Key responsibilities include:

• 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.

Why This Role Matters

This role sits at the intersection of Commercial Strategy, Field Execution, Data Analytics, and Compliance. Success requires a leader who can balance regulatory requirements with business needs, leverage data to drive decisions, influence cross-functional stakeholders, and ensure REMS programs effectively support both patient safety and commercial success.

Minimum 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.