Company Overview:

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 seen with other approaches. Dyne has a broad portfolio of programs for serious muscle diseases, including candidates for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on TwitterLinkedIn and Facebook.

Role Summary

The Associate Director, Clinical Operations collaborates with the Head of Clinical Operations and Study Leads to oversee the regional execution of studies, in assigned clinical program(s) in compliance with quality standards, support oversight of CROs and other third-party vendors to meet the Company’s obligations described in ICH-GCP and the Company’s objectives.

Applicants must be based in Europe. 

Primary Responsibilities Include:

  • Assist Clinical Study Leads in the development and maintenance of study oversight and management plans.
  • Liaise with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships
  • Provide subject matter expertise and operational input into study-related documents, including but not limited to clinical study protocol, pharmacy manual, monitoring plan, protocol deviation plan, and the communication plan to ensure compliance with the Company’s SOPs as required.
  • Oversee performance for all activities assigned to a CRO/vendor, including escalation of issues to Head of Clinical Operations and Quality Assurance team when required.
  • Contribute to initiatives to identify and implement best practices and continuous improvement plans in Clinical Operations.

 Education and Skill Requirements:

  • Bachelor’s degree in a scientific field required; advanced scientific degree a plus
  • Minimum 7 years directly managing clinical trials in Sponsor or CRO setting
  • In-depth knowledge of clinical trial operations, ICH-GCP Guidelines and other applicable regulatory requirements
  • Experience mentoring and directing members of clinical operations teams
  • Experience working in a team across multiple functional areas (e.g., Quality Assurance, Data Management, Biostats, Medical Writing, Safety, Clinical Supply Chain, Finance)

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.

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