Jobs at Dyne Therapeutics

The Senior Director leads the development of reporting and analytics for clinical operations, integrating data for decision-making and optimizing resources using advanced analytics and AI.

Lead Talent Acquisition operations, systems, programs, and reporting to scale hiring. Own ATS and integrations, design recruiting processes and governance, improve candidate and hiring-team experience, drive TA analytics and dashboards, ensure compliance, manage vendors and budgets, and partner cross-functionally to implement TA technology, automation, and continuous process improvements.

Partnering directly with the CCO, lead high-priority commercial strategy and cross-functional initiatives, shape the commercial operating model, prepare executive and Board materials, and drive decision-making and execution to support launch and growth of rare-disease therapeutics.

Lead the Trial Master File (TMF) strategy, ensuring compliance and quality oversight, while managing TMF operations across clinical portfolios and collaborating with cross-functional teams.

Lead biostatistical strategy and execution across clinical development programs. Design trials, author statistical sections and SAPs, oversee analyses and deliverables, support regulatory submissions and health authority interactions, manage CROs/vendors, mentor statisticians, and ensure submission-ready CDISC-compliant datasets, tables, listings, figures, and documentation.

Senior HR leader responsible for enterprise learning, leadership development, manager excellence, onboarding, succession planning, and workforce capability. Partners with executive teams to design scalable blended learning, measure impact with analytics, drive culture and change initiatives, and build a high-performing L&D function to support Dyne's growth.

The Director of Compliance ensures Dyne Therapeutics complies with laws, designs a global compliance program, and advises on commercial and regulatory matters. They lead risk assessments and collaborate with cross-functional teams while promoting a culture of integrity.

Lead strategy and execution of biologics CMC development from early-stage through clinical readiness. Drive process development, CDMO selection and technology transfer, author Module 3 content, ensure cGMP compliance, and provide cross-functional technical leadership to advance programs and optimize manufacturing cost and scalability.

Lead US commercial enablement by designing incentive compensation, optimizing CRM and BI systems, building field operations infrastructure, coordinating cross-functional launch readiness, and scaling processes to improve field effectiveness and operational excellence.

Lead generation of market, customer, and data-driven insights to inform commercial strategy across rare neuromuscular pipeline. Own global forecasting, market research, competitive intelligence, dashboards/KPIs, and advanced analytics. Partner cross-functionally to guide launch planning, access, budgeting, and executive decision-making while ensuring data governance and vendor management.

Manage end-to-end cold chain logistics for clinical and commercial supply, coordinating shipments between CMOs, warehouses, 3PLs and couriers. Lead network re-supply, ensure GMP/GDP and trade compliance, develop SOPs, support commercial launch 3PL setup, monitor vendor performance, troubleshoot issues, and partner with cross-functional teams to maintain supply continuity and documentation.

The Director of HCP Marketing leads strategies for engaging healthcare providers in Duchenne Muscular Dystrophy, focusing on launch execution, cross-functional collaboration, and utilizing insights for improved performance.

Lead Dynes enterprise procurement function, building source-to-pay strategy, processes, systems, and supplier management. Drive high-value sourcing, negotiations, compliance, cross-functional partnership, reporting on savings and risks, and CSR/ESG procurement initiatives to support growth and operational goals.

Lead GMP QA operations for CMOs, overseeing batch record review, product disposition, GMP investigations, CAPA, change management, and quality systems. Ensure FDA/EMA compliance, develop QA KPIs, monitor vendor quality, and collaborate cross-functionally to enable compliant clinical supply and commercialization readiness.

Lead design, scaling, and governance of a global, inspection-ready Quality Management System (QMS) supporting commercial readiness. Own document control, records management, training/eDMS/LMS, eQMS implementation, compliance with ICH/FDA/EU standards, inspection readiness, quality metrics, and cross-functional embedding of quality practices.

Lead global Quality Control for clinical and commercial programs, overseeing external labs, analytical operations, method qualification/validation, stability and release testing, OOS/OOT investigations, and regulatory CMC submissions. Build QC strategy and team capabilities, ensure cGMP compliance and inspection readiness, drive vendor performance and cross-functional alignment to support product disposition through BLA and commercialization.

Lead QA operations for external manufacturing and testing, overseeing GMP release activities, batch record review, investigations, CAPA, change control, quality systems, audits, CMO oversight, and cross-functional collaboration to ensure regulatory compliance and continuous improvement.

The Director of QA GMP Operations manages GMP quality for external and internal manufacturing, overseeing quality assurance activities and compliance. Responsibilities include managing deviations, QA support for tech transfer, and fostering collaboration across various teams.

Lead and oversee statistical programming across multiple clinical studies, ensuring CDISC-compliant datasets and TLFs, vendor coordination, submission readiness (eCTD), development of reusable tools/automation, mentoring junior staff, and contributing to departmental standards, processes, and strategy to support regulatory submissions and clinical decision-making.

Lead FP&A activities including budgeting, forecasting, financial modeling, variance and KPI analysis, and scenario planning. Own FP&A systems, reporting tools, and financial data warehouse development. Partner with Accounting, IT, and business leaders to deliver automated dashboards, actionable insights, and business cases supporting resource allocation, portfolio decisions, and board-level reporting.