Senior Director, Managed Access Programs

About this role

Company Overview:

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/ , and follow us on X , LinkedIn and Facebook .

Role Summary:

The Senior Director of Managed Access Programs (MAPs) leads the strategic direction and operational execution of managed access initiatives across the organization. This role is crucial in designing, implementing, and managing global programs that ensure patient access to our innovative therapeutics. This role develops policies and procedures that support equitable access while adhering to regulatory standards. This position collaborates closely with internal teams, including market access, HEOR, medical affairs, commercial, clinical, regulatory, supply chain, legal, and compliance to align MAP initiatives with the overall goals of the organization.

In addition, the person in this role partners with cross-functional teams to build and maintain strong relationships with key external stakeholders, to promote understanding and support for managed access programs. With a focus on data-driven decision-making, this role analyzes program performance, adjusting strategies as needed to maximize impact. By providing training and support to internal teams, this role ensures effective implementation of MAPs initiatives across the organization. Ultimately, this role plays a vital part in navigating complex access environments and improving health outcomes for patients.

This role is based in Waltham, MA.

Primary Responsibilities Include:

• Provide visionary leadership in the development and execution of managed access programs, ensuring that strategies align with Dyne Therapeutics' mission and objectives

• Build and oversee infrastructure necessary to implement managed access programs

• Oversee vendor responsible for program administration

• Foster a culture of collaboration and innovation within organization, guiding teams in effectively addressing patient needs and access challenges

• Design and implement comprehensive managed access policies and procedures that promote patient access to innovative therapies, with an emphasis on maintaining compliance with evolving regulatory requirements

• Utilize best practices and learnings from the field to continuously refine and enhance program frameworks

• Lead cross-functional teams, including Clinical Development, Regulatory Affairs, and Commercial, to ensure successful integration of managed access strategies across all stages of product development and commercialization

• Act as a key liaison, facilitating clear communication and alignment on priorities and objectives

• Establish and cultivate strong relationships with a diverse range of external stakeholders, including healthcare professionals, patient advocacy organizations, and regulatory bodies as appropriate

• Represent Dyne Therapeutics at conferences, meetings, and roundtable discussions, effectively advocating for managed access initiatives and fostering stakeholder trust and support

• Partner with HEOR, Market Access, Medical Affairs, and Clinical Development to implement data collection and analytics methodologies to assess program efficacy, patient outcomes, and potential access barriers

• Generate and present comprehensive reports to senior leadership and external stakeholders, offering actionable insights and recommendations for program improvement

• Develop and deliver targeted training programs and resources for internal teams regarding managed access processes, regulatory compliance, and best practices

• Ensure team is well-equipped to effectively engage with external partners and navigate complex access scenarios

• Continuously monitor and analyze industry trends, regulatory changes, and market dynamics that impact managed access programs

• Provide strategic recommendations to adapt and evolve Dyne Therapeutics' approach to access challenges in response to the shifting landscape

• Oversee the financial aspects of managed access programs, including budget planning, forecasting, and resource allocation

• Ensure that objectives are met while maximizing the impact of programs on patient access initiatives

• Foster a culture of excellence by encouraging feedback and facilitating continuous improvement within managed access programs

• Utilize lessons learned from program implementation and stakeholder interactions to drive innovation and enhance the overall effectiveness of initiatives

Education and Skills Requirements:

• Bachelor’s degree with rare disease experience in the biotech and/or pharmaceutical industry; neuromuscular experience preferred

• 15+ years of relevant experience in Medical Affairs and experience in leading global Managed Access Programs within the pharmaceutical/biotech industry; clinical operations experience also desirable

• Proven ability to lead global Managed Access Program development and implementation

• Excellent communication and relationship-building skills with KOLs and cross-functional teams

• Experienced in AI supported way of working

• Ability to interpret and communicate complex scientific data to diverse audiences

• Must be willing to travel up to 30%, inclusive of overnight and occasional weekends, to meet with customers, internal stakeholders and attend relevant conferences

• In-depth understanding of healthcare regulations, access environments, and the pharmaceutical industry landscape

• Familiarity with rare diseases and innovative

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