Senior Director, Managed Access Programs

Dyne Therapeutics•Waltham, MA

9h•Onsite

About The Position

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.

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 therapies is highly desirable
Strong leadership and interpersonal skills, with the ability to influence and drive cross-functional collaboration
Excellent analytical and problem-solving capabilities.
Exceptional verbal and written communication skills, with the ability to convey complex information clearly to diverse audiences (written, verbal and presentation)
Proven track record of developing and executing successful managed access strategies that improve patient access and outcomes
Excellent team player
Strong decision maker
Ability to work in a matrix environment
Ability to work independently as a hands-on manager, proactively contribute as a resource when necessary
Flexibility to adapt and meet the changing/growing needs of our customers
High level of integrity, compliance, ethics, and transparency
Positive team member who embodies Dyne’s Core Values
Excitement about Dyne’s vision and mission

Nice To Haves

neuromuscular experience preferred
clinical operations experience also desirable
Familiarity with rare diseases and innovative therapies is highly desirable

Responsibilities

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