Dyne Therapeutics · 1 day ago
Senior Manager, Clinical Supply
Waltham, MA
Full-time
Onsite
Senior Level
$143K/yr - $175K/yr
5+ years expDyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. The Senior Manager Clinical Supply manages clinical trial supply operations, ensuring supply continuity and readiness for upcoming clinical studies while collaborating with various internal and external stakeholders.
BiotechnologyHealth CareMedicalPharmaceutical
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
Qualification
Required
BS/BA degree 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
Preferred
Masters preferred in life sciences or business major or equivalent
Company
Dyne Therapeutics
Dyne Therapeutics is a developer of targeted therapies intended for serious muscle diseases.
51-200 employees
H1B Sponsorship
Dyne Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (7)
2023 (1)
2022 (3)
2021 (6)
Funding
Current Stage
Public CompanyTotal Funding
$1.67BKey Investors
Hercules CapitalAtlas Venture
2025-12-09Post Ipo Equity· $402.5M
2025-06-30Post Ipo Equity· $230M
2025-06-30Post Ipo Debt· $100M
Leadership Team
John Cox
Chief Executive Officer
Recent News
2025-12-24
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2025-12-24
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