Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue. Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and a preclinical program for facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
Role Summary:
The Senior Manager, TMF and Inspection Readiness will play a key role in the clinical operations department and is responsible for the day-to-day management of TMF files across all clinical trials at Dyne, including the upload, review, and approval of TMF documents.
The Senior Manager will co-author and manage TMF documents such as TMF Plan, Index, SOPs, and other guidance documents. The Senior Manager will also ensure quality management of studies by reporting TMF metrics periodic checks of adherence to SOPs, and reconciling all outstanding queries and issues e.g. CAPAs. This role will work closely with Clinical Operations in high-level projects, developing processes, and strategies and conducting training for TMF stakeholders. Responsible for overseeing the activities of external vendors ensuring that study documents are managed with adherence to ICH-GCP guidelines, other regulatory requirements, and internal and external standard operating procedures (SOPs) and that their assigned studies are inspection-ready.
The Senior Manager will also lead inspection readiness activities for Dyne clinical operations including management of clinical operations storyboards, coordination of inspection readiness activities and action items from preparatory meetings.
This role is based in Waltham, MA without the possibility of being remote.
Primary Responsibilities Include:
Education and Skills Requirements:
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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.