Associate Director, Clinical Operations

Job Description

Job Description

Job Title :

Associate Director, Clinical Operations

Reports to (title) :

Sr. Director, Clinical Operations

Solid Summary :

Solid Biosciences is a life science company focused on advancing a portfolio of neuromuscular and cardiac programs, including SGT-003, a differentiated gene therapy candidate for the treatment of Duchenne, AVB-401, a gene therapy program for the treatment of BAG3 mediated dilated cardiomyopathy, AVB-202-TT, a gene therapy program for the treatment of Friedreich’s Ataxia, and additional assets for the treatment of fatal cardiac diseases. Solid aims to be the center of excellence across a given disease spectrum bringing together those with expertise in science, technology, disease management, and care. Patient-focused and founded by those directly impacted, Solid’s mandate is to improve the daily lives of patients living with these devastating diseases.

Position Summary :

The successful candidate will manage clinical trial activities for multiple trials ensuring the timely completion of deliverables through development, management and oversight of the trial CROs, timeline and budget.

Partners with Clinical Development and other functions to develop operationally feasible and clear protocol concepts and final protocols. Must be comfortable independently leading internal study teams, as well as the outsourced activities and responsibilities delegated to CROs and / or other service providers for assigned clinical trials such as, study start-up, monitoring, site management, TMF, laboratories, drug supply and data management, and contribute to biostatistics, medical writing, safety, regulatory affairs and quality assurance activities, where needed. In addition, the successful candidate will interact closely with investigators and site staff through routine calls and site sponsor visits.

Key Duties & Accountabilities :

• 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.
• Responsible for management of the study teams for assigned studies or programs and of relationships with CROs, central labs, IRB’s, investigating sites and other external partners, as needed, for one or more clinical trials.
• Coordinates the activities of all trial conduct partners and team members and proactively identifies and manages risks
• Determine patient recruitment strategies, operational feasibility and implementation of study / program objectives
• Leads development and / or review of all supporting documents for a clinical study, registry or access program. including but not limited to Protocols, Informed Consent Forms, Investigator Brochures, Study Manuals, Statistical Analysis Plans, CRFs, Data Management Plans and Clinical Study Reports.
• Manage and lead cross-functional clinical trial team meetings collaborating with team members regarding operational activities pertaining to the execution of one or more clinical trial(s)
• Review clinical operations SOPs and work instructions within a program including, but not limited to, new hire training for CTMs / CRCs, tools, templates, and CRO manuals
• Identifies, or assists in identifying, investigational sites and participates in reviewing and approving qualified sites
• Create and review Request for Proposals, vendor specifications and participate in vendor selection process
• Manages the negotiation of contracts, budgets, and timelines with CROs, vendors, clinical sites, and other external partners
• Review study invoices and manage accruals for assigned studies monthly
• Leads the coordination of and training team members and external partners (vendors, sites, etc)
• Prepare and maintain assigned study and program files, study documentation and other essential documents
• Provide management with routine updates regarding the status of ongoing studies
• May participate in internal / external study related audits
• Ensure compliance to internal processes and GCP
• Ensure Trial Master File documentation is collected and maintained

Attend Investigator Meetings and site visits as needed

Core Competencies Required :

Knowledge : Education, Experience, & Skills :

Detail-oriented individual with good problem-solving capability

Travel Commitment : 10-20%

Role Location

(HQ, Hybrid, Remote, NC, etc.)

HQ, Hybrid or Remote