AstraZeneca

Director, Commercial REMS Operations - Pharmaceutical

AstraZeneca • $215K — $260K *
New Haven, CT 06511In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in a related discipline such as Business, Life Sciences, or Data Science.
  • 7+ years of experience in REMS programs within pharmaceuticals or biotechnology.
  • Demonstrated experience supporting a product with an active FDA REMS program.
  • Strong understanding of FDA REMS requirements and compliance obligations.
  • Experience managing vendors and ensuring performance metrics are met.
  • Proven leadership and stakeholder management skills with executive communication capabilities.
  • Advanced analytical skills, particularly in evaluating REMS effectiveness and business risks.

Responsibilities

  • Lead Commercial REMS strategy and operational execution across products.
  • Partner with internal teams to enhance REMS education and execution.
  • Translate REMS requirements into effective business processes and training.
  • Drive data-informed decision-making through analytics and reporting.
  • Oversee REMS data strategy and ensure quality governance.
  • Lead initiatives to improve REMS operational compliance and efficiency.
  • Manage relationships with vendors supporting REMS operations.

Benefits

  • Hybrid working model with an expectation to be onsite at least three days per week.
  • 401(k) plan with a retirement contribution option.
  • Paid vacation and holidays, along with paid leaves.
  • Health benefits including medical, prescription drug, dental, and vision coverage.
  • Short-term incentive bonus opportunities and equity-based long-term incentive programs.
Full Job Description
Director, Commercial REMS Operations

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

alternate: New Haven, CT

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.


Preferred Requirements
  • 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.


Location strategy

This position may be in either Boston, MA (Seaport) or New Haven, CT, depending on business needs and candidate preference. AstraZeneca follows a hybrid working model, with employees expected to be onsite at least three days per week in their assigned location. Candidates must possess the legal right to work in the relevant country; work visa eligibility and/or sponsorship requirements will be considered in accordance with local regulations. Remote work is not offered.

Pay transparency

The annual base pay for this position could range from $215,693 - $260,000 USD Annual. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered include a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employees will be in an "at-will position" and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Date Posted
11-Aug-2026

Closing Date
30-Oct-2026

About AstraZeneca

AstraZeneca is a British-Swedish multinational pharmaceutical company that specializes in the research, development, and manufacturing of prescription drugs. The company was formed in 1999 through the merger of Astra AB and Zeneca Group plc. AstraZeneca's products are used to treat a wide range of medical conditions, including cancer, cardiovascular disease, respiratory disease, and diabetes. The company has operations in over 100 countries and employs more than 76,000 people worldwide. AstraZeneca is committed to developing innovative medicines that improve the health and well-being of people around the world.
Learn more about AstraZeneca
Size
83,100 employees
Market Cap
$211.5 billion
Industry
Pharmaceuticals & Biotech
Net Income
$3.1 billion
Founded
1999
5 Year Trend
+10.2%
Revenue
$26.6 billion
NASDAQ
AZN
* Ladders Estimates

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