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 Director of Clinical Quality Assurance is responsible for leading Good Clinical Practice (GCP) Quality Assurance (QA) and serves as the GCP Quality representative for clinical study teams. This leader is skilled at building GCP processes and has in-depth knowledge of current GCP practices. This individual is the subject matter expert in GCP, is responsible for developing standards and partnering with Clinical Operations, Regulatory, Biostatistics, Safety, Medical Affairs, and other functions to establish and document risk based GCP processes and procedures. This role ensures compliance with applicable regulations with regards to sponsor oversight of Dyne’s clinical programs. This role is responsible for continuing to build out the quality infrastructure and evaluate, identify, and reduce compliance risk by contributing to the development and maintenance of efficient and effective clinical quality procedures to achieve the highest level of data quality and integrity.
This is a full-time position based in Waltham, MA without the possibility of being remote and requires ~25% travel.
Primary Responsibilities Include:
Educational and Skills Requirements
#LI-Onsite
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.