Sr. Manager, Risk Evaluation & Mitigation Strategy (REMS)

Sr. Manager, Risk Evaluation & Mitigation Strategy (REMS)

Who we are:

Agios is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selves to work. We care deeply about our work, each other, and the patients who count on us. Our teams cultivate strong bonds with patient communities, healthcare professionals, partners and colleagues, which helps us discover, develop and deliver therapies for rare diseases – and make a bigger difference in their lives. In the U.S., Agios markets a first-in-class pyruvate kinase (PK) activator for the treatment of hemolytic anemia in adults with PK deficiency. Building on the company’s leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia.

The impact you will make:

What you will do:

Strategic Delivery

• Participate in the implementation, oversight, and evaluation of REMS in alignment with the broader Program Strategy.
• Act as the in-house REMS expert across the organization.
• Assist in monitoring regulatory changes and proactively update strategies, policies, and procedures to align with FDA requirements and best practices.
• Participate on cross-functional teams to integrate REMS considerations into product development, launch, and lifecycle management strategies.

Cross-Functional & Matrix Partnership

• Participate in the cross functional development of implementation and operational plans that support the REMS.
• Perform REMS management and oversight in accordance with time, cost and quality commitments.
• Participate in matrix teams across MSRM, Regulatory Affairs, Medical Affairs, Market Access, Marketing, Quality, Supply Chain, Commercial, and Legal.
• Support provision of REMS strategy, progress, and compliance metrics to senior management and governance committees.

Operational Execution

• Perform and oversee timely execution of operational aspects of REMS and related case management/submission activities.
• Participate in the review or creation of REMS related documentation, including FDA requests, and vendor-authored documents as required.
• Support vendor oversight and management of day-to-day REMS operations, ensuring compliant enrollment, data collection, monitoring, and reporting.
• Generate KPIs, dashboards, and compliance metrics to measure REMS program effectiveness.
• Support readiness for regulatory inspections and audits; support noncompliance issue resolution, CAPA development and execution as needed.
• Develop and deliver input, guidance and training on REMS for case management and submission PV vendor
• General safety operations activities as assigned (eg: database user acceptance testing; vendor oversight)

• 
  Bachelor’s or Advanced degree in science, pharmacy, nursing, healthcare, or related field
• Minimum of 5 years of relevant drug safety/pharmacovigilance experience
• Strong knowledge of FDA REMS requirements Extensive knowledge and experience with MedDRA and WhoDD coding dictionaries
• Experience with software-based drug safety systems (ARGUS, ARISg, or equivalent)
• Excellent computer skills (MS Office)
• Advanced knowledge of US and EU pharmacovigilance regulations for development and marketed products
• Strong planning, process mapping, and organization skills
• Strong orientation to teamwork
• Excellent written/verbal communication and interpersonal skills

Preferred

• Audit and/or inspection experience in REMS and/or pharmacovigilance

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.
• Competitive performance-based compensation. This includes both short- and long-term incentives that are connected to our business strategy.
• The current base salary range for this position is expected to be between $131,035 – $196,553 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.