Director, Risk Evaluation & Mitigation Strategy; REMS

Director, Risk Evaluation & Mitigation Strategy (REMS) Who we are:

At Agios, we are fueled by connections to transform rare diseases. We foster an inclusive, collaborative culture – one that sparks bold thinking and strengthens our connections with each other and with the rare disease communities we serve. We embrace diverse backgrounds with respect, active listening, and a commitment to inclusion – because our differences shape how we hire, collaborate, and innovate.

Our team’s proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to develop innovative medicines that reflect the priorities of rare disease communities. Our commitment is more than scientific – it’s deeply personal, grounded in the meaningful connections we have built.

To learn more, visit  and follow Agios on Linked In and X.

Agios Pharmaceuticals is searching for a dynamic Director, Risk Evaluation & Mitigation Strategy (REMS) to join our growing Medical Safety & Risk Management team. We want someone who cares about this important work, and who’s driven to connect to our mission of helping these patient communities. The Director, Risk Evaluation & Mitigation Strategy (REMS) will be responsible for serving as the organizational lead for the design, implementation, and oversight of REMS programs.

This role combines strategic leadership, operational execution, and cross-functional collaboration. The Director will reside within Medical Safety & Risk Management (MSRM) and work closely with Regulatory Affairs, Medical Affairs, Market Access, Commercial, Supply Chain, and Legal teams, as well as external vendors, to deliver high-quality REMS programs that meet FDA requirements and support product success.

• Lead the implementation, oversight, and evaluation of REMS in alignment with the broader Program Strategy.
• Act as the in-house REMS expert across the organization.
• Monitor regulatory changes and proactively update strategies, policies, and procedures to align with FDA requirements and best practices.
• Partner with cross-functional teams to integrate REMS considerations into product development, launch, and lifecycle management strategies.

• Responsible for the cross functional development of implementation and operational plans that support the REMS.
• Accountable for REMS management and oversight in accordance with time, cost and quality commitments.
• Coordinate matrix teams across MSRM, Regulatory Affairs, Medical Affairs, Market Access, Marketing, Quality, Supply Chain, Commercial, and Legal.
• Communicate REMS strategy, progress, and compliance metrics to senior management and governance committees.

• Ensure timely execution of operational aspects of REMS and related activities.
• Review REMS related documentation, including FDA requests, and approve vendor-authored documents as required.
• Oversee vendor interactions and management of day-to-day REMS operations, ensuring compliant enrollment, data collection, monitoring, and reporting.
• Support integration of call centers, technology platforms, and other operational infrastructure as appropriate.
• Approve and manage program deliverables, budgets, and timelines.
• Develop and oversee KPIs, dashboards, and compliance metrics to measure program effectiveness.
• Ensure readiness for regulatory inspections and audits; support noncompliance issue resolution, CAPA development and execution as needed.

• Bachelor’s or Advanced degree in science, pharmacy, nursing, healthcare, or related field.
• 10+ years of pharmaceutical/biotech industry experience, with expert knowledge and proven track record on REMS operations.
• Proven track record in vendor management, program implementation, and compliance oversight.
• Demonstrated success leading cross-functional and matrix teams.
• Strong knowledge of FDA REMS requirements and evolving regulatory landscape.
• Experience implementing SOPs and compliance frameworks.
• Excellent communication, project management, and organizational skills.

• Advanced degree (Pharm
  
  D, PhD, MSN, MPH, MBA, or…