Senior Director, Clinical Data Systems & Clinical Programming

Solid Biosciences•Charlestown, MA

About The Position

Solid Biosciences is a precision genetic medicine company advancing gene therapy candidates for rare neuromuscular and cardiac diseases. The Senior Director, Clinical Data Systems & Clinical Programming will provide strategic leadership and operational oversight for clinical technology platforms, clinical database programming, data integrations, and vendor partnerships across the clinical development portfolio. The role will develop and execute a scalable clinical systems strategy that supports high-quality, efficient, compliant, and inspection-ready trials. The Senior Director will oversee systems and processes for electronic data capture (EDC), interactive response technology (IRT), electronic clinical outcome assessments (eCOA/ePRO), clinical data repositories, and related applications. The role works closely with Clinical Data Management, Statistical Programming, Biostatistics, Clinical Operations, Clinical Supply, Regulatory Affairs, Quality, IT, and third-party vendors. It also includes building and developing a clinical systems and clinical programming organization, balancing internal capabilities with external partnerships and flexible resourcing models.

Requirements

Bachelor’s degree in life sciences, computer science, information systems, biostatistics, engineering, or a related field.
15 or more years of progressive experience in clinical systems, clinical data management, database programming, biometrics operations, or related clinical development functions within biotechnology, pharmaceutical, or CRO environments.
Demonstrated leadership experience managing people, vendors, complex programs, budgets, and cross-functional initiatives, including establishing functional strategy, governance, standards, and scalable operating processes.
Extensive experience supporting Phase 1 through Phase 3 clinical trials and global development programs.
Significant expertise in EDC database development, IRT, eCOA/ePRO, computerized systems validation, data integrations, external data, clinical data flows, and database lock processes.
Deep working knowledge of EDC platforms such as Medidata Rave, Veeva CDMS, Oracle InForm, or comparable systems.
Knowledge of clinical data standards, metadata, data lineage, repositories, APIs, cloud-based platforms, and data quality monitoring.
Strong knowledge of GCP, 21 CFR Part 11, computerized systems validation, data integrity, and applicable global regulatory expectations.
Experience supporting audits, regulatory inspections, and inspection readiness activities.
Strategic judgment and ability to translate portfolio needs into pragmatic technology and operating plans, bridge clinical, operational, technical, quality, and regulatory perspectives, and manage multiple priorities in a dynamic, resource-conscious biotechnology environment.
Excellent vendor management, negotiation, communication, and stakeholder leadership skills.

Nice To Haves

Advanced degree or an equivalent combination of education and relevant industry experience.
Familiarity with SQL, SAS, R, Python, or other relevant programming technologies.
Experience in rare disease, gene therapy, biologics, or specialty biotechnology.

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.
Oversee 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.
Lead governance for randomization, trial supply management, eCOA/ePRO, and other patient- or site-facing technologies; ensure protocol requirements are 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 platforms and external data providers.
Lead the design and evolution of clinical data flows, repositories, integration patterns, and data lineage capabilities with IT, Data Management, Biostatistics, and Statistical Programming.
Oversee secure and reliable data transfers, interfaces, APIs, and ingestion workflows; establish standards for metadata, traceability, data quality monitoring, issue management, and technical documentation.
Lead 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 processes comply with GCP, 21 CFR Part 11, data integrity principles, company procedures, and applicable global regulations, with complete, traceable, current, 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, contributing to protocol development, study planning, vendor selection, and operational readiness, and communicating decisions, risks, dependencies, and performance to leadership and study teams.
Build and develop a high-performing clinical systems and clinical programming organization, defining roles, resource plans, operating models, objectives, and development opportunities.

Benefits

Competitive health and dental programs with flexible plan offerings, including FSA and HSA programs.
401(k) program with competitive company matched contributions.
Eligibility to participate in the Employee Stock Purchase Plan.
Mobile phone subsidy for eligible employees.
Tuition reimbursement.
Vision coverage.
Life insurance.
Voluntary pet insurance.
Employee discount program on travel, entertainment, and services.
Employee Assistance Programs.
Daily subsidized lunch delivery for employees onsite at Hood Park.
Free onsite full-service gym for employees onsite at Hood Park.
Employee parking for employees onsite at Hood Park.
12 observed holidays and a winter shutdown.
15-day PTO policy with an 80-hour year-over-year rollover.
40-hour sick policy.
8-hour floating holiday.
Short-term and long-term incentives, including cash bonus and equity incentive opportunities, for regular employees.