Director, Commercial REMS Operations - Pharmaceutical
$215,693–$260,000 year
HybridBoston, Massachusetts, United States
Job Summary
Lead commercial strategy, operational execution, and governance for REMS programs across Alexion and AstraZeneca's rare disease portfolio. Partner with Commercial, Sales Operations, Patient Services, Regulatory, Safety, Ethics & Compliance, IT, and external vendors to ensure alignment, operational excellence, and compliance. Translate regulatory requirements into scalable business processes, field capabilities, and training strategies while driving data-informed decision making through analytics and performance monitoring. Oversee vendors supporting REMS operations and reporting solutions, support launch readiness and program optimization, and present strategic recommendations to senior leadership. Work onsite three days per week in Boston or New Haven.
Required Qualifications
- 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
- Candidates must possess the legal right to work in the relevant country
- Work visa eligibility and/or sponsorship requirements will be considered
- Employees expected to be onsite at least three days per week in their assigned location
- Remote work is not offered
- This position may be in either Boston, MA (Seaport) or New Haven, CT, depending on business needs and candidate preference
Desired Qualifications
- 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
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