Director, Commercial REMS Operations - Pharmaceutical

Job description

**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. **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. **Why join us?** At Alexion, AstraZeneca Rare Disease, you will be part of a team driven by science, urgency, and purpose. We are committed to pushing boundaries for patients with rare diseases, and we know that achieving this takes exceptional people, strong collaboration, and a culture where different perspectives are welcomed. This is an opportunity to take on a strategic and impactful role at the intersection of commercial operations, compliance, data, and patient safety. You will work across a wide stakeholder network, help shape how REMS programs are delivered, and contribute to the success of both current and future products. **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. When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace, and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. **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 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.