Executive Director, Head of Clinical Operations

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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