Senior Director, Clinical Data Management, Therapeutic Area Lead, Hematology

About this role

Job Description

The Senior Director, Clinical Data Management Therapeutic Area (TA) Lead, Hematology   provides strategic and operational oversight of data management delivery across the assigned therapeutic area(s). The role leads portfolio planning, resource and performance management, and cross-functional alignment to ensure execution against GDMS and enterprise priorities. The Senior Director partners with TA, Geographies (Geo), and Capability Leads to optimize efficiency, standardization, and digital enablement across programs, while driving quality, compliance, and continuous improvement within the TA organization. 

Responsibilities  • Accountable for TA (Therapeutic Area) portfolio strategy and prioritization, developing the TA roadmap and study sequencing, and balancing resources, timelines, and risks to meet enterprise commitments.  • Partner with Clinical Data Manager Geographic Leadership to ensure seamless global delivery, effective knowledge sharing, in depth understanding of protocols, risk-based data management and quality-by-design execution proportionate to study design and therapeutic area risk management across all in-scope data modalities.  • Partner with Clinical, BARDS (Biostatistics and Research Data Science), GDIA (Global Data Integration & Automation), GCDS (Global Clinical Data Standards), and platform/analytics teams to embed standards, automation, and data-integration practices into TA operating models; define requirements, drive adoption of fit-for-purpose tools, establish TA dashboards and Key Performance Indicators (KPIs), and scale successful automation pilots.  • Forecast capability and capacity needs across regions and programs in partnership with Portfolio and Geographic Leads, optimizing onshore, offshore, and contingent delivery models.  • Lead TA-wide quality governance, inspection readiness, and risk management; harmonize Corrective And Prevention Action (CAPA) tracking across the portfolio; and present TA performance in reviews with recommended corrective actions and structural improvements.  • Serve as escalation point for complex study and program issues; capture and scale lessons learned and best practices; and partner with GDMS (Global Data Management & Standards), GCTO (Global Clinical Trial Operations), and GCD (Global Clinical Development) leadership on enterprise-aligned transformation initiatives (including but not limited to process, standards, and platform / tools), ensuring consistent cross-regional adoption and alignment with digital, data, and regulatory guardrails.  • Set clear objectives aligned to organizational goals; assign work and set priorities.  • Conduct regular check-ins and annual reviews; coach for performance; provide recognition.  • Develop career plans; create growth opportunities and promotion cases; ensure appropriate training and mentoring.  • Lead recruiting and hiring; manage sensitive employee-relations matters in partnership with HR.  • Balance workloads to support value-added work and work–life sustainability; anticipate obstacles and adjust plans.  • Coordinate on-shore/off-shore and contingent resources; ensure role clarity and effective handoffs.  • Manage an operating budget and optimize spend against priorities.  • Align teams around a clear direction; facilitate team/functional meetings.  • Provide concise, decision-ready updates and status reporting to leadership and partners. 

Global Capability Leadership (as assigned)    • Sit on the CDM (Clinical Data Management) Leadership team as the representative for their assigned capability   • Contributes to/ leads execution of the strategic objectives and roadmap for capability development initiatives aligned to business needs and industry best practices.   • Supports governance aligned to GDMS/GCTO policies and enterprise digital / data initiatives.   • Own development of critical capabilities (tools, processes, skills) aligned to business needs and industry best practices.  • Establish capability governance aligned with GDMS/GCTO policies and enterprise digital/data initiatives.  • Drive consistent global rollout via playbooks, guidance, and implementation support; align cross-regional ways of working with partners. 

Technical skills  • Deep experience leading end-to-end data management for clinical trials, including database design/build/UAT (User Acceptance Training), edit checks/validation, review/reconciliation, database lock, and the design, validation, and maintenance of DM (Data Management) deliverables using relevant Clinical Data Manager platforms and enabling technologies.  • Deep understanding of data structures and integrations across EDC (Electronic Data Capture) and connected systems (e.g., labs, IRT [Interactive Response Technology], eCOA [electronic Clinical Outcome Assessment], imaging), with a demonstrated ability to triage and resolve complex study-level issues to maintain data integrity across internal systems and service providers.  • Advanced knowledge across two or more Therapeutic Areas, applying TA-specific scientific and operational expertise to shape indication- and TA-level data management strategy, planning, resource allocation, and execution.  • Comprehensive knowledge of the clinical development lifecycle, data flow, and cross-functional dependencies (Clinical Operations, Biostatistics, Safety, Data Standards, Regulatory), supported by a deep understanding of clinical practice and medical terminology.  • Advanced proficiency in CDISC (Clinical Data Interchange Standards Consortium) standards (CDASH [Clinical Data Acquisition Standards Harmonization], SDTM [Study Data Tabulation Model], Define-XML), metadata management, and controlled terminologies (e.g., LOINC [Logical Observation Identifiers Names and Codes]) to ensure consistency and submission readiness.  • Working knowledge of SOPs (Standard Operating Procedures), ICH-GCP (International Council for Harmonization – Good Clinical Practice), 21 CFR Part 11/Annex 11, and pr

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