VP, Clinical and Commercial 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:

VP, Clinical and Commercial Supply is responsible for the management of both clinical and commercial supply which includes integrated planning, forecasting and project management, shipping international and domestic, storage and clinical distribution, and management of drug product activities for clinical and launch commercial supply. In addition, they are responsible for the build out of a commercial supply chain organization to support and execute the launch of two lead assets. This role is fully accountable for end-to-end clinical supply management in our organization. The position requires a deep understanding of supply chain networks, clinical regulations, commercial regulations, timelines, end-to-end planning and analytics to facilitate communications across a variety of functions and to develop cost-effective clinical supply solutions balancing multiple business objectives.

This role works closely with key stakeholders including CMC, external Manufacturing, Procurement, R&D, Clinical, Regulatory Affairs, Project Management, Commercial and Corporate leadership to define and build the capabilities required to effectively manage Dyne’s complex clinical/commercial supply chain and support eventual launch and commercialization efforts while maintaining additional clinical assets.

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

Primary Responsibilities Include:

• Lead the development and implementation of clinical supply planning models with input from clinical operations, CMC, and external manufacturingOversee suppliers and vendors involved in materials planning, inventory control, logistics, distribution to ensure that batch manufacturing is completed on a timely basis
• Lead process improvement initiatives and author clinical supply SOPs
• Enable successful clinical trials using supply chain management processes (Plan, Source, Make, Deliver, and Return)
• Working with external manufacturing, responsible for integrated project management of all CMC vendors ensuring all stakeholders support inventory required to fulfill research, pre-clinical and clinical needs
• Responsible for storage and shipping of all pre-clinical and clinical intermediates, domestic and international
• Lead commercial launch planning, forecasting and inventory models closely working with commercial, external manufacturing and CMC.
• Develop inventory plans for each vendor in the supply network; communicate with external manufacturing on supply demand forecast with rolling 18 months
• Provide commercial non-binding and binding 2 year view to external manufacturing
• Build a commercial supply chain plan prior to BLA, and revise for post-BLA improvements
• Support QA compliance with cGMPs, cGLPs and guidance for clinical trial materials
• Support the development of regulatory CMC documentation and partner due diligence
• Work with partner organizations as necessary to ensure that timelines are met, milestones and products are delivered on schedule, and any excursions, deviations, investigations, and CAPAs are initiated, addressed and closed within target timeframes

 

Education and Skills Requirements:

• A minimum of 15 years of relevant biopharmaceutical CMC and/or Engineering experience
• Degree in Business, Engineering, biochemistry, chemistry or similar related field required
• Proven experience in processes and systems to support biopharmaceutical development
• Expertise in investigation of complaints, product rejections, non-conformances, recalls, deviations, and trends from process performance and product quality monitoring and experience implementation of Corrective Actions and Preventive Actions (CAPA) resulting from these investigations
• Knowledge of ERP/MRP computerized control systems, inventory control methods, distrib