Director, Risk Evaluation & Mitigation Strategy (REMS)

Role Summary

Agios Pharmaceuticals is seeking a dynamic Director, Risk Evaluation & Mitigation Strategy (REMS) to join our Medical Safety & Risk Management team. The Director will be the organizational lead for the design, implementation, and oversight of REMS programs, combining 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.

Responsibilities

• Strategic Leadership: 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.
• Cross-Functional & Matrix Leadership: 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.
• Operational Execution: 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.

Qualifications

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

Additional Requirements

• Location: Location Agnostic. Role can be remote in the US or hybrid in Cambridge Headquarters; travel may be required for company events as described.