Agios Pharmaceuticals · 3 weeks ago
Director, Risk Evaluation Mitigation Strategy (REMS)
United States
Full-time
Remote
Director/Executive
$184K/yr - $275K/yr
10+ years expAgios Pharmaceuticals is a company committed to transforming rare diseases through inclusive and collaborative culture. They are seeking a Director of Risk Evaluation & Mitigation Strategy (REMS) to lead the design, implementation, and oversight of REMS programs, ensuring compliance with FDA requirements and supporting product success through strategic leadership and cross-functional collaboration.
BiotechnologyHealth CareMedicalPharmaceutical
Hiring Manager
Michelle Brown
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
Qualification
Required
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
Benefits
Deliberate Development.
Flexibility.
Premium benefits package.
Competitive and equitable performance-based compensation.
Psychological safety.
Commitment to diversity.
Commitment to community.
Company
Agios Pharmaceuticals
Agios Pharmaceuticals is a biopharmaceutical company discovers and develops therapeutics in the field of cancer metabolism.
501-1000 employees
H1B Sponsorship
Agios Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (11)
2024 (9)
2023 (10)
2022 (7)
2021 (10)
2020 (12)
Funding
Current Stage
Public CompanyTotal Funding
$775.82MKey Investors
Celgene
2020-12-21Acquired
2019-11-07Post Ipo Equity· $256M
2018-01-17Post Ipo Equity· $400M
Leadership Team
Brian Goff
Chief Executive Officer and Board of Directors Member
James Burns
Chief Legal Officer
Recent News
2025-12-25
Company data provided by crunchbase