Director, Risk Evaluation & Mitigation Strategy (REMS)

Contract Director, Risk Evaluation & Mitigation Strategy (REMS)
Who we are:
This 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., our company 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, we are 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:

We are searching for a dynamic Contract Director, Risk Evaluation & Mitigation Strategy (REMS) to join our dedicated 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 Contract Director, REMS will serve as the organizational lead for the design, implementation, and oversight of REMS program. This role combines strategic leadership, operational execution, and cross-functional collaboration. The position will work closely with Regulatory Affairs, Medical Affairs, Pharmacovigilance, Safety, 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

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  Lead the development, implementation, and evaluation of REMS in alignment with broader Program Strategy.
  
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  In-house REMS expert across the organization.
  
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  Monitor regulatory changes and proactively update strategies, policies, and procedures to align with FDA requirements and best practices.
  
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  Partner with cross-functional teams to integrate REMS considerations into product development, launch, and lifecycle management strategies.
  

Cross-Functional & Matrix Leadership

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  Responsible for the cross functional development of implementation and operational plans that support the REMS.
  
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  Accountable for REMS management and oversight in accordance with time, cost and quality commitments.
  
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  Coordinate matrix teams across Regulatory Affairs, Pharmacovigilance, Medical Affairs, Market Access, Marketing, Quality, Supply Chain, and Legal.
  

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  Communicate REMS strategy, progress, and compliance metrics to senior management and governance committees.
  

Operational Execution

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  Ensure timely execution of operational aspects of REMS and related activities.
  
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  Review REMS related documentation, including FDA requests, and approve vendor- authored documents as required.
  
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  Oversee vendor interactions and management of day-to-day REMS operations, ensuring compliant enrollment, data collection, monitoring, and reporting.
  
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  Support integration of call centers, technology platforms, and other operational infrastructure as appropriate.
  
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  Approve and manage program deliverables, budgets, and timelines.
  
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  Develop KPIs, dashboards, and compliance metrics to measure program effectiveness.
  
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  Ensure readiness for regulatory inspections and audits; support CAPA development and execution as needed.
  

What you bring:

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  Bachelor’s or Advanced degree in science, pharmacy, nursing, healthcare, or related field. Advanced degree (PharmD, PhD, MSN, MPH, MBA, or related) preferred.
  
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  8+ years of pharmaceutical/biotech industry experience, with expert knowledge and proven track record on REMS operations and oversight.
  
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  Proven track record in vendor management, program implementation, and compliance oversight.
  
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  Demonstrated success leading cross-functional and matrix teams.
  
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  Strong knowledge of FDA REMS requirements and evolving regulatory landscape.
  
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  Experience implementing SOPs and compliance frameworks.
  
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  Excellent communication, project management, and organizational skills.
  
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  Experience with audit inspection or pharmacovigilance preferred.