United States onlyCompany 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:
The Senior Manager, Clinical Supply oversees trial supply activities, including budgeting, logistics, and compliance with multinational regulations and GxP requirements for drug development (Phases 1/2-4). This role involves managing complex trial supplies, project management, IVRS/IRT functionality, and global distribution, while collaborating with internal teams (Tech Ops, Clinical Ops, Quality, Regulatory Affairs, etc.) and external partners (CMOs, CROs) to ensure timely material availability. The position also handles problem-solving, timeline management, and quality systems (deviations, investigations, CAPAs, and Change Control) to support clinical trial strategies and timelines.
This role is based in Waltham, MA without the possibility of being a fully remote role.
Primary Responsibilities Include:
Oversee and schedule contract manufacturing packaging, labeling, and international shipping/distribution operations for Investigational Medicinal Product (IMP) 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 Interactive Voice Response Systems (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 5 years of related experience in the pharmaceutical industry with at least 3 years of direct experience in Global Clinical Supply Management.
- Bachelors degree in Business Administration or Supply Chain preferred
- Experience managing a contract manufacturing required
- Experience utilizing (Interactive Response Tech)IRT, electronic Trial Master File (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
- 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
- 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.
