Executive Director, Geo Lead & Global Capability Lead, Clinical Data Management Services (US)

MSD•Rahway, NJ

1d•Hybrid

About The Position

Reporting directly to the Head of their assigned functional area and acting as a member of their Leadership Team, the Executive Director, Functional Area Geography Lead leads global geographic strategy and performance across assigned region/ geography. They are responsible for translating functional area and Global Data Management and Standards (GDMS) strategic imperatives into region-specific priorities and plans. The role partners with GDMS and Global Clinical Trial Operations (GCTO) leaders to drive global alignment, standardization, and transformation of data-management practices, represents their function and geography network in GDMS Leadership Team forums, and ensures resource excellence, capability growth, and operational readiness worldwide.

Requirements

Enterprise-level expertise in GDMS data operations, governance, and digital enablement strategy.
Strong understanding of end-to-end data management processes and systems used for data collection, application of data standards, cleaning/review, reporting, governance, and use of operational and quality metrics to monitor performance.
Proven experience implementing risk-based and digital data practices across multiple regions; ability to integrate regional business intelligence into enterprise-level strategy.
Deep understanding of inspection/audit processes and ability to contribute to audit readiness.
Deep knowledge of ICH/GCP (International Council of Harmonization - Good Clinical Practices) guidelines and how they apply to clinical or safety data management activities.
Deep understanding of quality standards and frameworks across GDMS/ GCTO; experience with data standards, data flow, and study start-up systems; ability to define and implement standards for integration, reuse, and scalability of data, tools, and solutions across regions.
Advanced knowledge of data management industry best practices, innovation levers, and regulatory evolution shaping data management globally.
Deep expertise in data-product governance (definitions, lineage, quality controls, lifecycle) to maintain a global single source of truth; deep understanding of clinical trial lifecycle.
Advanced knowledge of regional risk, escalation, and capacity-management processes.
Advanced ability to use analytical and forecasting tools (dashboards, capacity models) to inform resourcing, planning, and operational decisions.
Working knowledge of SDLC (Software Development Life Cycle), CSV (Computer System Validation), data privacy, and inspection-readiness requirements for system introduction or change at scale.
Proven financial stewardship of 200+ person organizations, including budget ownership, investment cases, workforce cost modeling, and value-realization frameworks.
Expertise in automation and AI-enabled planning and reporting, with fluency in validation expectations in regulated environments; enterprise-level mastery of AI-First operating-model governance (standards, controls, ethics) and tool-stack roadmap stewardship across geographies.
Executive communication and storytelling skills with the ability to influence senior leadership decisions.
Strong stakeholder management, demonstrated enterprise leadership, and collaboration capabilities across functions and geographies.
Demonstrated ability to lead through influence, motivating and guiding cross-functional and virtual teams without direct authority.
Ability to integrate business, operational, and people dimensions into effective, data-informed decision-making.
Ability to shape culture, guide transformation, and build organizational capability at scale.
Strong governance judgment balancing compliance, quality, delivery, and innovation.
Tailors messaging up, across, and down; engages stakeholders; influences senior leaders and provides clear, actionable feedback.
Strong ability in negotiation and conflict resolution and aligning divergent priorities to enterprise outcomes and enforces clear responsibilities.
Demonstrated ability to drive large-scale change, embed innovation, and lead continuous improvement initiatives, while ensuring adoption of standardized, risk-based, and digital practices.
Demonstrated disciplined prioritization focused on critical metrics and high-value initiatives.
Highly adaptable and resilient under pressure, exercising sound judgment and initiative while maintaining alignment with organizational priorities.
Ability to develop leaders with broad business context, accountability, and execution excellence.
Champions change, continuous improvement and innovation, while ensuring adoption of standardized, risk-based, and digital practices.
Fluent in English with excellent written and verbal communication skills to clearly convey complex or technical information.
Bachelor's Degree with 15 years of experience working in the relevant field Life Sciences or Pharmaceutical industry, including: 5 years of people management experience.
Demonstrated deep subject matter expertise in the area of people and process management.
Demonstrated experience in successfully implementing strategy utilizing various methodologies to solve problems in complex organizational structure.
OR Advanced Degree (Masters or Doctorate) with 13 years of experience working in the relevant field Life Sciences or Pharmaceutical industry, including: 5 years of people management experience (direct or matrix).
Demonstrated deep subject matter expertise in the area of people and process management.
Demonstrated experience in successfully implementing strategy utilizing various methodologies to solve problems in complex organizational structure.
Clinical Data Management
Clinical Data Standards
Clinical Operations
Clinical Trials
Continuous Improvement
Cross-Functional Collaboration
Cross-Functional Leadership
Delivery Management
Digital Implementation
Digital Partnerships
Executive Communications
Executive Leadership
Process Management
Project Management
Regulatory Compliance
Risk Management

Nice To Haves

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Current Contingent Workers apply HERE
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Responsibilities

Lead global geography strategy and oversee multiple regions/countries to ensure excellence in functional management and regulatory compliance, while embodying ELS (Enterprise Leadership Skills) values.
Report to the functional area head; serve on the respective functional area leadership team; represent geographic and functional perspectives in GDMS (Global Data Management & Standards) Leadership Team, enterprise forums, and audits for assigned regions.
Collaborate with cross-functional (non-GDMS) leadership and enterprise support functions within assigned geographies to achieve strategic and operational goals and objectives.
Embed process-excellence and governance frameworks across regions.
Shape and implement digitally-enabled operating models; drive global alignment, standardization, and transformation.
Champion a culture of collaboration, innovation, and accountability across the network; ensure ongoing improvement and operational excellence.
Partner with leaders across GDMS, GCTO, and Global Clinical Development (GCD) to drive consistent rollout / adoption of capabilities, including alignment of cross-regional ways of working with partners.
Oversee performance governance, financial discipline, and global talent planning; sponsor leadership development and succession.
As assigned, serve as the GDMS Site Head for the relevant country or region.
Partner with Country and Regional business support functions (e.g., HR, Finance) to enable local business priorities.
Ensure consistent operational execution, quality, and compliance across assigned geographies.
Jointly accountable with Portfolio & Resource Operations and non-GDMS leaders for planning, resourcing, and operational governance across regions; set priorities for resource allocation, capability development, and continuous improvement or process innovation to achieve strategic and operational goals.
Serve as escalation point for country/regional issues; and oversee region-specific risk, escalation, and capacity-management processes; ensure local regulatory, business, and labor compliance.
Drive adoption of leading-edge technology deployment principles across relevant GCTO organizations and functions.
Lead complex cross-functional workstreams driving automation, data integrity, and operational excellence from idea/design through implementation and value realization.
Run geography scenario planning and resilience playbooks for demand shocks, surges, and reprioritization; protect critical work and service levels.
Accountable for defining the strategic objectives and roadmap for capability development initiatives aligned to business needs and industry best practices.
Establish and oversee capability governance with GDMS/ GCTO policies and enterprise digital / data initiatives.
Own development of critical capabilities (tools, processes, skills) aligned to industry best practices.
Drive consistent global rollout via playbooks, guidance, and implementation support; align cross-regional ways of working with partners.
Provide strategic input and feedback to Capability Leads on capability development initiatives, including capability roadmaps and strategic objectives.
Align teams around a clear direction; set clear objectives aligned to organizational goals; assign work and set priorities accounting for work-life balance sustainability.
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 and oversee performance management activities, including management of sensitive employee-relations matters in partnership with HR.
Coordinate on-shore/off-shore and contingent resources; ensure role clarity and effective handoffs.
Manage an operating budget and optimize spend against priorities.
Inspires and ensures that team leaders are effectively supporting and empowering their individual leaders.