Agios Pharmaceuticals

Compensation

Full Description

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 www.agios.com and follow Agios on LinkedIn and X. The impact you will make: 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. 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 noncompliance 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. We are dedicated to building an inclusive, diverse, equitable, and accessible environment where all employees can bring their whole selves to work. If you’re excited about this role but your previous experience doesn’t align perfectly with the job description, we still encourage you to apply. You may be just the right candidate for this role or another opening! Work Location: Location Agnostic: Work location for this role is based on employee's individual preference. This role has the ability to be either remote in the US or hybrid in 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 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. • 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 including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. • 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. Interested in learning more about what makes our culture unique? Visit the Inside Agios section of our website.