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Executive Director, Head of Clinical Operations

Department: 121 Clinical Operations

Location: Waltham, MA

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 Executive Director, Head of Clinical Operations, is accountable for the resourcing, development, training, and management of a highly performing clinical operations team, including clinical data management, and strategic oversight and execution (within budget and timelines) of clinical plans. The person in this role must thrive in a fast-paced environment where flexibility, accountability, and teamwork are paramount, and share a passion for Dyne’s mission to bring transformative therapies to people living with serious muscle diseases. Additionally, this individual must have excellent interpersonal skills and be able to analyze complex issues to develop strategies to successfully implement clinical trial plans. 

This role is based in Waltham, MA without the possibility of being a remote role. Applicants must be able to relocate to the area.

Primary Responsibilities Include:

  • Provide strategic operational guidance to ensure that trials are properly defined, planned, and executed to a high degree of quality across all clinical stage programs.
  • Develop and implement a clinical vendor oversight process with documentation to record transfer of regulatory responsibilities, evaluation of performance, and escalation of issues.
  • Establish, implement, and proactively manage clinical trial processes, strategic outsourcing, and performance indicators.
  • Ensure high standards for compliance and quality within the Clinical Operations and Data Management team and across clinical trial vendors with company SOPs, ICH-GCP guidelines that govern regulations, and patient safety standards.
  • Regularly report clinical trial status, identify challenges and program/resource gaps, and devise and implements solutions.
  • Provide strategic input to clinical-trial related risk analysis and mitigation strategies.
  • Provide operations input into trial-related documentation and regulatory submissions.
  • Lead the development and review of clinical program budgets, and track and forecast spend for initiated studies.
  • Lead or oversee the authorship of Clinical Operations and Data Management SOPs and other function-specific documentation; participate in cross-functional SOP development and infrastructure initiatives.
  • Recruit, mentor and develop Clinical Operations and Data Management staff.

Education and Skill Requirements:

  • BS/BA in a scientific discipline with at least 20 years of relevant clinical operations experience; or, MS or PhD in a scientific discipline and 15 years of relevant clinical operations experience.
  • Previous Clinical Operations functional and/or program leadership, including hiring and managing Clinical Operations  staff, selecting and managing vendors/CROs, and optimizing resources across clinical studies.
  • Experience implementing clinical trial management systems, including TMF, EDC, IXRS.
  • Experience running global clinical trials from initial feasibility through to CSR delivery.
  • Detailed knowledge of clinical research practices, FDA/EMA regulations and ICH GCP Guidelines regarding drug development in all phases, and data management methods.
  • Familiarity with European GDPR legislation and managing emerging impact on clinical trial conduct.
  • Experience running trials in rare disease preferred.
  • NDA/BLA regulatory filing experience preferred.
  • Excellent communication and presentation skills.

 

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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.


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