Solid Biosciences · 3 months ago
Associate Director, Clinical Operations
Charlestown, MA, US
Full-time
Hybrid
Lead/Staff, Director/Executive
$145K/yr - $215K/yr
8+ years expSolid Biosciences is a life science company focused on advancing a portfolio of neuromuscular and cardiac programs. 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.
BiotechnologyGeneticsHealth CareMedical
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
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
Qualification
Required
Minimum BA/BS Degree
Minimum 8 years of Clinical Trial Management experience
Must be willing to travel, both domestic and international
Demonstrated knowledge and understanding of FDA/EMA/GCP/ICH regulations and guidelines
Ability to provide appropriate leadership to clinical sites and CROs
Ability to manage and operationalize a high volume of highly complex tasks within a given timeline
Ability to lead cross functional team in a matrix environment
Strong multi-tasking, time management, and organizational skills
Ability to take initiative and work both independently and in a team environment
Detail-oriented individual with good problem-solving capability
Benefits
Full Benefits
Company
Solid Biosciences
Solid Biosciences is a life science company that conducts research for the treatment of Duchenne muscular dystrophy.
51-200 employees
H1B Sponsorship
Solid Biosciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (3)
2023 (2)
2022 (4)
2021 (2)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$810.3MKey Investors
Ultragenyx PharmaceuticalPerceptive AdvisorsJP Morgan
2025-02-18Post Ipo Equity· $200M
2024-01-08Post Ipo Equity· $109M
2022-09-30Post Ipo Equity· $75M
Leadership Team
Alexander Cumbo
CEO and President
Kevin Tan
Chief Financial Officer
Recent News
2025-12-24
2025-12-17
Company data provided by crunchbase