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 develop a high-performing clinical systems and clinical programming organization, defining roles, resource plans, operating models, objectives, and development opportunities while balancing internal capabilities with external partnerships and flexible resourcing models.
Experience Requirements
- Bachelor's degree in life sciences, computer science, information systems, biostatistics, engineering, or a related field required; advanced degree or an equivalent combination of education and relevant industry experience preferred.
- 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 establishment of functional strategy, governance, standards, and scalable operating processes.
- Extensive experience supporting Phase 1 through Phase 3 clinical trials and global development programs, with 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, as well as 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, with experience supporting audits, regulatory inspections, and inspection readiness activities.
- Strategic judgment and the 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; familiarity with SQL, SAS, R, Python, or other relevant programming technologies and experience in rare disease, gene therapy, biologics, or specialty biotechnology are preferred.
Compensation
The base compensation range for this role is: $285,325 - $296,793
Base salary offered is determined through an internal analysis utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short-term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward individual performance and align incentives to Solid’s long term company performance.
Benefits and Solid Advantages
At Solid Biosciences we offer a highly competitive total rewards and benefits package, intended to support all aspects of our employees’ lives and well-being. Additionally, for those employees working onsite at our Hood Park Headquarters, we offer a variety of onsite resources to support those working in our offices.
- Competitive Health and Dental programs with flexible plan offerings, including FSA and HSA programs
- 401(k) program participation with competitive company matched contributions
- Eligibility to participate in Solid’s 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 (onsite @ Hood Park)
- Free Onsite Full-Service Gym (onsite @ Hood Park)
- Employee Parking (onsite @ Hood Park)
- 12 Observed Holidays and a winter shut down
- 15-day PTO Policy and a 80-hour rollover YoY
- 40-hour Sick Policy
- 8 Hour Floating Holiday
Skills Required
- 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
- Leadership experience managing people, vendors, complex programs, budgets, and cross-functional initiatives
- Experience establishing functional strategy, governance, standards, and scalable operating processes
- Experience supporting Phase 1 through Phase 3 clinical trials and global development programs
- Expertise in EDC database development, IRT, eCOA/ePRO, computerized systems validation, data integrations, external data, clinical data flows, and database lock processes
- 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
- Knowledge of GCP, 21 CFR Part 11, computerized systems validation, data integrity, and global regulatory expectations
- Experience supporting audits, regulatory inspections, and inspection readiness activities
- Strategic judgment and ability to translate portfolio needs into technology and operating plans
- Vendor management, negotiation, communication, and stakeholder leadership skills
- Advanced degree or 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
What We Do
Solid Biosciences is a precision genetic medicine company developing gene therapy candidates for rare neuromuscular and cardiac diseases. Its pipeline includes programs for Duchenne muscular dystrophy, Friedreich’s ataxia, catecholaminergic polymorphic ventricular tachycardia, and genetic cardiomyopathies. The company also develops genetic regulators and other enabling technologies intended to improve gene-therapy delivery. Founded by people directly affected by Duchenne, its mission is to improve daily life for patients with rare diseases.
