Vice President, Head of Clinical Operations

Company 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 Vice President, Clinical Operations is accountable for the resourcing, development, training, and management of a highly performing clinical operations team, and strategic oversight and execution (within budget and timelines) of clinical plans. A successful candidate 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 position reports to the Senior Vice President, Portfolio Strategy and Operations

This role is based in Waltham, MA without the possibility of being fully remote.

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
• Evolve the Clinical Operations Department Infrastructure
• Lead initiatives to build the clinical operations department infrastructure
• Plan clinical operations headcount and hiring needs to meet program workload demands
• Establish, implement, and proactively manage clinical trial processes, strategic outsourcing, and performance indicators.
• Ensure high standards for compliance and quality within the Clinical Operations 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 authorship of Clinical Operations SOPs and other function-specific documentation
• Recruit, mentor and develop Clinical Operations staff
• Ensure that clinical trials are properly resourced, managed, executed and inspection ready in accordance with timelines, good quality practices and applicable regulatory requirements
• Participate in development of a life-cycle strategy and evaluation of new programs to be prioritized or advanced into clinical development
• Develop clinical timelines, budget forecasts, and ensure accountability for tracking and deliverables
• Collaborate with others on the development of protocols, annual safety reports, clinical study reports, publications, presentations and regulatory submissions
• Regularly present clinical operations updates and strategy to Dyne’s Executive Committee
• Represent and advocate for clinical operations needs and resources at the Executive Committee level

Education and Skills Requirements:

• BS/BA in a scientific discipline with at least 15 years of relevant clinical operations experience; or,MS or PhD in a scientific discipline and 12 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.