Senior Manager, Clinical Supply

Dyne Therapeutics•Waltham, MA

2d•Onsite

About The Position

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 myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and 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 https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook. Role Summary: The Senior Manager Clinical Supply manages, and monitors activities related to ongoing clinical trial operations and systems to ensure supply continuity. In addition, the role supports readiness of the clinical label and pack set up, global trial distribution network and clinical trial systems for upcoming clinical studies. The Senior Manager closely interfaces Clinical Operations, Quality, Product Development, Regulatory Affairs, Contract Manufacturing Organization (CMO), Contract Research Operations (CRO’s) and clinical sites to ensure clinical trial supply material is available as required and readiness of the clinical supply network work support the clinical trial strategy. The clinical supply team also provides critical input to set the clinical trial strategy. This is a full-time position based in Waltham, MA

Requirements

BS/BA degree (Masters preferred) in life sciences or business major or equivalent required.
5+ years of related experience in the pharmaceutical or biotech industry with at least 3 years of direct experience in global clinical supply management.
Experience leading contract manufacturing is required.
Excellent interpersonal and organizational skills.
Ability to work and influence across different functions and stakeholders
High collaborative team-player who fosters open communication, facilitates mutual understanding, drives alignment and effectively maintains relationships with key internal and external stakeholders.
Proven ability to manage external vendors
Operational experience managing material movements across global CMOs, 3PLs, warehouses, and Test Labs.
Proactive problem solver and self-directed individual with the ability to operate independently in a complex, fast-paced environment.
Ability to set clear objectives, effectively plan, prioritize, and anticipate challenges and drive execution per plan.

Responsibilities

Oversee clinical supply operations, including labeling, packaging, distribution, and resupply across global depots
Manage depot and site inventory in collaboration with Trial Managers; ensure timely IMP and placebo shipments globally
Coordinate labeling and packaging activities with Clinical CMOs and monitor international shipping and distribution
Manage exceptions in Quality Systems (deviations, investigations, CAPAs, specifications, and change controls)
Ensure readiness of labeling, packaging, and distribution networks for future trials
Align with Supply Planning on demand forecasts, manufacturing outputs, and supply continuity; reconcile inventory and shipments monthly
Lead development and updates of pharmacy manuals for Phase I–III trials; provide input to clinical strategy and study protocols
Manage product returns, replacements, and destruction in collaboration with Clinical Operations and Quality
Identify and implement process improvements; act as SME during regulatory audits
Represent Clinical Supply on global project teams and collaborate cross-functionally to build capabilities
Author and maintain SOPs and work instructions for inventory, IRT, labeling, distribution, returns, and destruction
Coordinate shipments between CMOs, warehouses, 3PLs, test labs, and other nodes
Support network resupply with internal teams and external partners (couriers, customs brokers, CMOs)
Ensure compliant, timely shipments including documentation, booking, tracking, and closure
Troubleshoot logistics issues and implement corrective actions