Senior Director, Clinical Data Systems & Clinical Programming

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.