Associate Director, Clinical Operations

Role Summary

Associate Director, Clinical Operations – Solid Biosciences. HQ Hybrid or Remote. Manage clinical trial activities for multiple trials, overseeing CROs, timelines, and budgets; collaborate with Clinical Development to develop protocols; lead internal study teams and outsourced activities; interact with investigators and site staff; report to the Senior Director, Clinical Operations. Based in Charlestown, MA or remote.

Responsibilities

• Provide strategic planning expertise, define and implement development program strategy and departmental objectives in alignment with corporate goals.
• Responsible for effective global management of multiple clinical studies within a clinical development program.
• Manage study teams and relationships with CROs, central labs, IRBs, investigating sites, and other external partners for one or more trials.
• Coordinate activities of trial conduct partners and team members; proactively identify and manage risks.
• Determine patient recruitment strategies, operational feasibility, and implementation of study objectives.
• Lead development and/or review of all supporting documents for a clinical study, registry, or access program (Protocols, ICFs, Investigator Brochures, Study Manuals, SAPs, CRFs, DMPs, CSRs).
• Manage and lead cross-functional clinical trial team meetings; coordinate operational activities for trials.
• Review SOPs and work instructions; contribute to new hire training for CTMs/CRCs, tools, templates, and CRO manuals.
• Identify or assist in identifying investigational sites; review and approve qualified sites.
• Create and review RFPs, vendor specifications; participate in vendor selection.
• Negotiate contracts, budgets, and timelines with CROs, vendors, sites, and external partners; review invoices and manage accruals Monthly.
• Lead coordination and training of team members and external partners.
• Prepare and maintain study/program files and essential documents; provide routine status updates.
• Participate in internal/external study-related audits; ensure compliance with internal processes and GCP; maintain Trial Master File.
• Attend Investigator Meetings and site visits as needed.

Qualifications

• Ability to manage and operationalize a high volume of highly complex tasks within a timeline.
• Ability to lead cross-functional teams in a matrix environment.
• Strong multi-tasking, time management, and organizational skills.
• Ability to take initiative and work independently and in a team.
• Minimum BA/BS Degree.
• Minimum 8 years of Clinical Trial Management experience.
• Willingness to travel domestically and internationally.
• Knowledge of FDA/EMA/GCP/ICH regulations and guidelines; ability to lead clinical sites and CROs.
• Detail-oriented with good problem-solving capability.

Skills

• Strategic planning and program management
• Stakeholder and vendor management
• Regulatory compliance and quality assurance
• Document development and study conduct documentation
• Budget and contract negotiation
• Leadership of cross-functional teams

Education

• BA/BS required

Additional Requirements

• Travel required (domestic and international).