Director, Risk Evaluation & Mitigation Strategy (REMS)
Kinsley Power Systems, Cambridge, MA, United States
Director, Risk Evaluation & Mitigation Strategy (REMS)
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 will be responsible for serving as the organizational lead for the design, implementation, and oversight of REMS programs.
The role combines strategic leadership, operational execution, and cross‑functional collaboration. The Director resides within Medical Safety & Risk Management (MSRM) and works 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.
What you will do: 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 non‑compliance issue resolution, CAPA development and execution as needed.
What you bring: Qualifications
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.
Preferred
Advanced degree (PharmD, PhD, MSN, MPH, MBA, or related).
Audit and/or inspection experience in REMS and/or pharmacovigilance.
Concerned that you don’t check off every box in the requirements listed above? Please apply anyway! At Agios, we value each other’s differences and recognize that teams thrive when everyone brings their unique experiences to the table.
Work Location Location Agnostic: Work location for this role is based on employee's individual preference. The role can be remote in the US or hybrid at our Cambridge Headquarters. Hybrid schedules vary but are generally less than 3 days per week onsite, and hybrid employees are expected to live within commutable distance to our Cambridge Headquarters. Remote employees work entirely from home except for attending Company‑sponsored events/meetings. For employees who choose to work remotely, travel may be required for certain company events commensurate to the above job description.
What we will give you:
Deliberate Development.
Your professional growth is 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.
Premium benefits package.
We invest in health, wellbeing, and security of our people with a premium benefits package that is well‑rounded and flexible.
Competitive and equitable performance‑based compensation.
This includes base salary and short‑ and long‑term incentives that are connected to our business strategy and vary based on individual and company performance.
The current base salary range for this position is expected to be between $183,549 – $275,324 annualized; final salary will be determined based on various factors.
Psychological safety.
We support an environment of fearlessness.
Commitment to diversity.
We strive to foster a welcoming workplace where everyone can thrive.
Commitment to community.
We’re an active participant in the communities that surround us.
Interested in learning more about what makes our culture unique? Visit the Inside Agios section of our website.
#J-18808-Ljbffr
The role combines strategic leadership, operational execution, and cross‑functional collaboration. The Director resides within Medical Safety & Risk Management (MSRM) and works 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.
What you will do: 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 non‑compliance issue resolution, CAPA development and execution as needed.
What you bring: Qualifications
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.
Preferred
Advanced degree (PharmD, PhD, MSN, MPH, MBA, or related).
Audit and/or inspection experience in REMS and/or pharmacovigilance.
Concerned that you don’t check off every box in the requirements listed above? Please apply anyway! At Agios, we value each other’s differences and recognize that teams thrive when everyone brings their unique experiences to the table.
Work Location Location Agnostic: Work location for this role is based on employee's individual preference. The role can be remote in the US or hybrid at our Cambridge Headquarters. Hybrid schedules vary but are generally less than 3 days per week onsite, and hybrid employees are expected to live within commutable distance to our Cambridge Headquarters. Remote employees work entirely from home except for attending Company‑sponsored events/meetings. For employees who choose to work remotely, travel may be required for certain company events commensurate to the above job description.
What we will give you:
Deliberate Development.
Your professional growth is 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.
Premium benefits package.
We invest in health, wellbeing, and security of our people with a premium benefits package that is well‑rounded and flexible.
Competitive and equitable performance‑based compensation.
This includes base salary and short‑ and long‑term incentives that are connected to our business strategy and vary based on individual and company performance.
The current base salary range for this position is expected to be between $183,549 – $275,324 annualized; final salary will be determined based on various factors.
Psychological safety.
We support an environment of fearlessness.
Commitment to diversity.
We strive to foster a welcoming workplace where everyone can thrive.
Commitment to community.
We’re an active participant in the communities that surround us.
Interested in learning more about what makes our culture unique? Visit the Inside Agios section of our website.
#J-18808-Ljbffr