Senior Director, Clinical Data Systems
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Job Description
Senior Director, Clinical Data Systems & Clinical Programming - Solid Biosciences
Hybrid / Remote
Solid Biosciences is a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neuromuscular and cardiac diseases, including Duchenne muscular dystrophy (Duchenne), Friedreich’s ataxia (FA), catecholaminergic polymorphic ventricular tachycardia (CPVT), TNNT2-mediated dilated cardiomyopathy, BAG3-mediated dilated cardiomyopathy, and additional fatal, genetic cardiac diseases. We are advancing a diverse pipeline and delivery platform in the pursuit of uniting experts in science, technology, disease management, and care.
Patient-focused and founded by those directly impacted by Duchenne, Solid’s mission is to improve the daily lives of patients living with devastating rare diseases.
We are seeking a Senior Director, Clinical Data Systems & Clinical Programming to provide strategic leadership and operational oversight for clinical technology platforms, clinical database programming, data integrations, and associated vendor partnerships across the clinical development portfolio. This role will develop and execute a scalable clinical systems strategy that supports high-quality, efficient, compliant, and inspection-ready clinical trials. The Senior Director will oversee systems and processes supporting electronic data capture (EDC), interactive response technology (IRT), electronic clinical outcome assessments (eCOA/ePRO), clinical data repositories, and related applications, partnering closely with Clinical Data Management, Statistical Programming, Biostatistics, Clinical Operations, Clinical Supply, Regulatory Affairs, Quality, IT, and third-party vendors.
Key Position Responsibilities
- Develop and execute the clinical systems and clinical programming roadmap, including governance, standards, lifecycle management, system ownership, decision rights, controls, documentation expectations, and escalation pathways across EDC, IRT, eCOA/ePRO, clinical data repositories, and related platforms.
- Provide strategic and operational oversight for EDC database design, configuration, programming, validation, release, maintenance, and archival, including standards for electronic case report forms, edit checks, derivations, database specifications, testing, and documentation.
- Provide leadership and governance for randomization, trial supply management, eCOA/ePRO, and other patient- or site-facing clinical technologies, ensuring protocol requirements are accurately translated into specifications, test plans, procedures, and validated configurations.
- Partner with Clinical Supply and Clinical Operations to align enrollment assumptions, randomization requirements, dispensing logic, and supply forecasts, and ensure reliable integrations and reconciliations across clinical technology platforms and external data providers.
- Lead the design and evolution of scalable clinical data flows, repositories, integration patterns, and data lineage capabilities in partnership with IT, Data Management, Biostatistics, and Statistical Programming.
- Oversee secure and reliable data transfers, interfaces, APIs, and ingestion workflows, establishing standards for metadata, traceability, data quality monitoring, issue management, and technical documentation to enable timely access to integrated clinical data.
- Lead the evaluation, selection, contracting, governance, financial oversight, and performance management of clinical technology vendors and service providers, including scopes of work, budgets, timelines, deliverables, risks, change orders, and continuity planning.
- Ensure clinical systems and supporting processes comply with GCP, 21 CFR Part 11, data integrity principles, company procedures, and applicable global regulations, with complete, traceable, current, and inspection-ready validation documentation.
- Partner with Quality and IT on risk assessments, audits, deviations, corrective and preventive actions, access controls, business continuity, system retirement, inspection readiness, and health authority interactions involving clinical systems, databases, and data flows.
- Serve as the senior subject matter expert for clinical systems and clinical database programming, providing strategic input during protocol development, study planning, vendor selection, and operational readiness and communicating key decisions, risks, dependencies, and performance to leadership and study teams.
- Build and dev
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