Director, REMS Commercial Strategy & Operations

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

Job summary

Alexion, AstraZeneca Rare Disease in Boston is seeking a Director of Commercial REMS Operations to shape REMS strategy and drive cross-functional execution across US Commercial teams. This high-visibility role partners with Sales Operations, Regulatory, Safety, IT, Patient Services, and external vendors to ensure compliant, scalable REMS programs that support patient safety and commercial success.

The role requires 7+ years in REMS, strong leadership, and deep knowledge of FDA REMS requirements,

Qualifications

• Bachelor's degree in Business, Life Sciences, or related field.
• 7+ years supporting REMS programs in pharma/biotech.
• Commercial experience supporting a product with an active FDA REMS program.
• Experience partnering with cross-functional Commercial leadership and related teams.
• Proven REMS strategy, operational execution, and governance leadership.
• Strong understanding of FDA REMS requirements and program optimization.
• Ability translating regulatory requirements into commercial processes and education.

Responsibilities

• Lead REMS strategy, operational execution, governance, and performance.
• Partner with field teams and enablement to strengthen REMS education and execution.
• Translate REMS requirements into scalable business processes and training.
• Drive data-informed decision making through reporting and analytics.
• Oversee vendor relationships and performance against compliance standards.
• Support launch readiness and ongoing REMS program optimization.

Skills

REMS strategy

Cross-functional leadership

Commercial operations

Data analytics

Education

Bachelor's degree

Tools

SQL

Python

Data visualization

Job description

Alexion, AstraZeneca Rare Disease in Boston is seeking a Director of Commercial REMS Operations to shape REMS strategy and drive cross-functional execution across US Commercial teams. This high-visibility role partners with Sales Operations, Regulatory, Safety, IT, Patient Services, and external vendors to ensure compliant, scalable REMS programs that support patient safety and commercial success.

The role requires 7+ years in REMS, strong leadership, and deep knowledge of FDA REMS requirements,