Associate Director, Site Engagement

This role will lead study startup across programs and serve as a site advocate, building institutional knowledge of site operations as well as tools and best practices for study startup and ease of execution. A primary goal is to achieve high quality site relationships by providing efficiency and consistency for sites and positioning Dyne as the Sponsor of choice for our partner sites. This position requires substantive experience with clinical study operations at sites and CROs, flexibility in approaches to solutions and communications.

Key Responsibilities of the Role:

• Manage study startup activities to meet timelines and set up sites and study teams for successful execution
• Perform Feasibility assessments for potential partner clinical trial sites
• Coordinate the development of clinical documents such as informed consent forms, pre-site selection, site initiation and training materials
• Negotiate site-level and vendor budgets, CTAs and MSAs, developing a standardized process across programs
• Assess CRO and vendor materials to ensure reduced burden on sites, increase understanding and efficiency, and streamline documentation and training
• Develop and maintain reports and other materials capturing site processes and institution knowledge to guide study teams and leadership to informed decisions related to site selection and study management
• Serve as a focal point of escalation for operational concerns about or from sites and apply lessons learned across studies and programs
• Serves as subject matter expert in site operations across therapeutic areas and regions, advocating for investigators and research coordinators proactively offering solutions and opportunities to maximize ease and speed of study execution
• Performs on-site visits with partner sites to improve relationships and start-up efficiencies
• Procure and maintain a Clinical Trial Management System to monitor site-related metrics
• Direct initiatives to identify and implement best practices, mitigate risks, and continuous improvement plans for study startup and site relationships
• Establish and evaluate site-related business processes, including the development of new SOP’s and work practices for best-in-class site management

 Education and Skills Requirements:

• Bachelor’s Degree or equivalent with significant demonstrable related experience in pharmaceutical / biotech in a GCP-regulated environment
• 5+ years of working in clinical research and drug development with specific experience in site start-up/ activation
• In-depth knowledge of clinical trial operations, ICH-GCP and other applicable regulatory requirements
• Experience working in a team across multiple functional areas (e.g., Regulatory, Finance, Legal, Quality Assurance, Medical Writing)
• Intellectual curiosity, innovation and creative problem solving
• Ability to think critically in fast-paced environment with a keen sense of urgency
• Self-motivated and able to work autonomously, as well as a collaborative member of a team
• Highly organized and detail-oriented with a passion to deliver high-quality results
• Strong verbal and written communication skills with an ability to build relationships both internally and externally
• Highest levels of professionalism, confidence, personal values and ethical standards