Senior Manager, Clinical Supply

Company Overview:

Dyne Therapeutics is discovering and advancing innovative life-transforming therapeutics for people living with genetically driven neuromuscular diseases. Leveraging the modularity of its FORCE™ platform, Dyne is developing targeted therapeutics that deliver to muscle and the central nervous system (CNS). Dyne has a broad pipeline for neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. For more information, please visit https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook. 

Role Summary: 

The Senior Manager, Clinical Supply oversees trial supply activities, including budgeting, logistics, and compliance with multinational regulations and GxP requirements for drug development (Phases 1/2-4). This role involves managing complex trial supplies, project management, IVRS/IRT functionality, and global distribution, while collaborating with internal teams (Tech Ops, Clinical Ops, Quality, Regulatory Affairs, etc.) and external partners (CMOs, CROs) to ensure timely material availability. The position also handles problem-solving, timeline management, and quality systems (deviations, investigations, CAPAs, and Change Control) to support clinical trial strategies and timelines. 

This role is based in Waltham, MA without the possibility of being a fully remote role. 

  
Primary Responsibilities Include: 

• Oversee and schedule contract manufacturing packaging, labeling, and international shipping/distribution operations for Investigational Medicinal Product (IMP) and Placebo ensuring on time delivery to support clinical trials 

• Provide technical expertise for the development of clinical study protocols and pharmacy manuals for phase 1-4 compounds and will be required to develop dosing and administration strategies for complex biologic products in early phases of development 

• Lead the planning, creation and maintenance of IMP supply project plans, based on study forecasts with Clinical Operations, Clinical Development and contracted vendors 

• Manage Trial and Quality Systems required documentation, including on-time open and close of Deviations, Investigations, CAPA’s, Change Controls, Label and Product Specifications, and others as required 

• Evaluate, select, and implement contract manufacturing, packaging, and labeling operations. Negotiate supply/technical agreements, oversee operations, and act as primary liaison between clinical personnel and contractor(s) on assigned projects 

• Identify process improvement opportunities, recommends pathways for solutions and drives idea generation, proposals and implementation 

• Direct and monitor clinical supply contractor set up, progress and implements corrective actions when issues arise 

• Manage development and implementation of Interactive Voice Response Systems (IVRS) supply and drug return strategy with contractors and sites 

• Manage Clinical Supplies inventory for projects assigned by interfacing with contractor to ensure that inventory systems are kept up-to-date and that final product reconciliation is accurately completed 

• Assist program teams with supporting and communicating with clinical sites regarding supply needs, storage and return of clinical supplies 

• Develop Standard Operating Procedures (SOPs) and guidelines related to inventory management, distribution, transportation, disposition of returned/unused materials 

• Ensure that key supply project milestones are met; negotiates and communicates supply plan timelines to internal and external customers and partners 

• Proactively drive cross-functional activities. Works with other line functions and external partners to manage complex projects