Director, Risk Evaluation & Mitigation Strategy (REMS)

Agios Pharmaceuticals Inc•Cambridge, MA

6d•Hybrid

About The Position

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.

Requirements

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.

Nice To Haves

Advanced degree (PharmD, PhD, MSN, MPH, MBA, or related).
Audit and/or inspection experience in REMS and/or pharmacovigilance

Responsibilities

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.

Benefits

Deliberate Development. Your professional growth as one of our top priorities.
Flexibility. We’re all about individual needs. We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity. When you’re at your best, we’re at our best.
Premium benefits package. We invest in the health, wellbeing, and security of our people with a premium benefits package that is well-rounded and flexible to help meet the varied personal and professional needs of every member of our team. For more detail on the benefits we offer at Agios, visit the Inside Agios section of our website.
Competitive and equitable performance-based compensation. This includes base salary and both short- and long-term incentives that are connected to our business strategy and vary based on individual and company performance.
Psychological safety. We support an environment of fearlessness. We want you to share your ideas, speak candidly and take data-informed risks to help push the boundaries.
Commitment to diversity. We strive to foster a welcoming workplace where everyone can thrive. We’re continuously looking to improve the inclusivity of our workforce.
Commitment to community. We’re an active participant in the communities that surround us – the communities where we live, and the community of people and their loved ones in need of better treatment options for conditions that are often overlooked.

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