Strategic Director, Commercial REMS Operations

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

Job summary

Alexion, AstraZeneca Rare Disease is seeking a Director of Commercial REMS Operations to lead REMS strategy and execution across US Commercial activities. You will partner with Commercial, Sales Operations, Patient Services, Regulatory, Safety, IT, and external vendors to ensure compliance and business success.

The role focuses on scalable REMS programs, data-driven decision making, and cross-functional governance, with a hybrid work model in Boston or New Haven and a strong emphasis on patient

Qualifications

• Bachelor’s degree in business, life sciences, CS, IS, data science, engineering or related field.
• 7+ years of experience supporting REMS programs in pharma/biotech.
• Commercial experience with a product that has an active FDA REMS program.
• Experience partnering with cross-functional Commercial leadership and related teams.
• Proven REMS strategy, operational execution, and governance in a complex matrix.
• Strong understanding of FDA REMS requirements and program optimization.
• Ability translating regulatory requirements into effective commercial processes.
• Advanced analytics to evaluate REMS effectiveness and risk identification.
• Experience managing external vendors and third-party partnerships.
• Strong leadership and executive communication across functions.

Responsibilities

• Lead REMS strategy, execution, governance, and performance across products.
• Partner with field teams and Commercial enablement to strengthen REMS education and execution.
• Translate REMS requirements into scalable business processes and training strategies.
• Drive data-informed decision making through reporting and insights.
• Oversee REMS data strategy, governance, quality, and reporting.
• Lead cross-functional initiatives to improve REMS effectiveness and compliance.
• Oversee vendors supporting REMS operations, analytics, and reporting solutions.
• Support launch readiness and ongoing REMS optimization.
• Present risks, opportunities, and strategic recommendations to senior leadership.

Skills

REMS strategy

Cross-functional collaboration

Data analytics

Vendor governance

Regulatory compliance

Executive communication

Education

Bachelor's degree in a related field

Job description

Alexion, AstraZeneca Rare Disease is seeking a Director of Commercial REMS Operations to lead REMS strategy and execution across US Commercial activities. You will partner with Commercial, Sales Operations, Patient Services, Regulatory, Safety, IT, and external vendors to ensure compliance and business success.

The role focuses on scalable REMS programs, data-driven decision making, and cross-functional governance, with a hybrid work model in Boston or New Haven and a strong emphasis on patient