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 Director, Clinical Supply plans, establishes, manages, and monitors activities related to trial supply including budgets to support the drug development process (Phases 1/2,3,4), in cooperation with internal and external customers and partners in compliance with multinational regulations as well as internal procedures and GxP requirements. Responsibility for supporting complex studies trial supply requiring project management, IVRS/IRT functionality, distribution, and supply logistics such as packaging/labeling and transporting supplies globally, and TMF. This position will closely interface with Tech Ops, Clinical Ops, Quality, Product Development, Regulatory Affairs, Contract Manufacturing Operations (CMO’s), and Contract Research Operations (CRO’s) to ensure clinical trial material is available as required and support clinical trial strategy and timelines. This position also interacts directly with clinical sites and CRO’s.

In addition, the Director, Clinical Supply will face complex problems related to clinical trial supply and will be required to negotiate on timelines and activities with external and internal entities to ensure supply is available for patients. The Director, Clinical Supply will continuously track progress towards objectives and advise management of any issues impacting project timelines and provide solutions to the problems. Responsible for actively managing all Quality Systems related to Clinical Supply Chain including deviations, investigations, CAPA’s and Change Control.

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

Primary Responsibilities Include:

• Direct/oversee and schedule contract manufacturing packaging, labeling, and international shipping/distribution operations for IMP (Investigational Medicinal Product) 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 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.
• Participate as SME for clinical regulatory audits related to supply.
• Represent Clinical Supply on global clinical project teams.

Education and Skills Requirements:

• Minimum of 10 years of related experience in the pharmaceutical industry with at least 5 years of direct experience in Global Clinical Supply Management
• Experience managing a contract manufacturing required
• Experience utilizing IRT, eTMF, and other clinical study related systems recommended
• Excellent interpersonal, organizational, negotiation and communication skills; team member must work collaboratively with colleagues across all functions
• Ability to communicate and maintain collaborative relationships effectively with key internal and external stakeholders
• Proven ability to select, secure and manage external vendors at a manager level to achieve results and control costs
• Ability to establish clear expectations and priorities, sets objectives and effectively apply resources
• Ability to set clear goals and consistently deliver
• Flexible and creative problem-solving skills
• Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
• Self-directed individual who can work effectively with limited direction in a complex, fast-paced environment
• Experience in rare disease a plus

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.

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.