Dyne Therapeutics
Senior Manager, Clinical Supply
Dyne Therapeutics, Waltham, Massachusetts, United States, 02254
Company Overview
Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We develop therapeutics that target muscle and the central nervous system 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. Learn more at https://www.dyne-tx.com, and follow us on X, LinkedIn and Facebook.
Role Summary Senior Manager Clinical Supply manages and monitors activities related to ongoing clinical trial operations and systems to ensure supply continuity. The role supports readiness of the clinical label and pack set up, global trial distribution network, and clinical trial systems for upcoming clinical studies.
Clinical Trial Supply
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.
Network Logistics Support
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.
Education, Experience, and Skills Requirements
BS/BA degree (Master's 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.
Pay Range $143,000 - $175,000 USD
Equal Employment Opportunity Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
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Role Summary Senior Manager Clinical Supply manages and monitors activities related to ongoing clinical trial operations and systems to ensure supply continuity. The role supports readiness of the clinical label and pack set up, global trial distribution network, and clinical trial systems for upcoming clinical studies.
Clinical Trial Supply
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.
Network Logistics Support
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.
Education, Experience, and Skills Requirements
BS/BA degree (Master's 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.
Pay Range $143,000 - $175,000 USD
Equal Employment Opportunity Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
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