Director, Clinical Data Management, Strategy and Operations Lead - Hybrid

Job Description Responsibilities
1. Strategy, Planning & Prioritization

• Partner with BVSV and Platform Services leadership to translate strategy into priorities, roadmaps, operational plans, and measurable outcomes.
• Establish an integrated planning process linking demand, portfolio commitments, resources, capacity, and organizational priorities.
• Facilitate prioritization and investment discussions to ensure focus on the highest-value opportunities.
• Monitor progress against strategic objectives and identify risks, dependencies, and areas requiring leadership action.

• Lead the governance framework for BVSV and Platform Services, including leadership forums, decision management, escalation processes, and performance reviews.
• Serve as a strategic partner and Chief of Staff to the leadership team.
• Ensure decisions, commitments, and actions are tracked through execution.
• Develop executive communications, strategic updates, and leadership materials.

• Provide an integrated view of service demand, delivery commitments, backlog, resource capacity, and organizational priorities.
• Support intake, assessment, and prioritization processes across validation and platform services.
• Identify capacity constraints, competing priorities, and resource risks and support leadership decision-making.
• Ensure commitments remain aligned with available resources and strategic objectives.

• Establish and maintain organizational KPIs, dashboards, scorecards, and performance reporting.
• Provide leadership visibility into service performance, demand, capacity, quality, risks, and strategic outcomes.
• Drive measurement of business value, operational efficiency, quality improvements, and organizational performance.
• Translate data into actionable insights and recommendations.

• Lead operational excellence and transformation initiatives across BVSV and Platform Services.
• Drive simplification, standardization, automation, and process improvement opportunities.
• Promote data-driven decision-making and adoption of AI and automation capabilities where appropriate.
• Ensure improvements are sustainable and aligned with organizational goals.

• Understanding of compliance and documentation standards (e.g., GxP, 21 CFR Part 11, and audit traceability practices)
• Deep experience in Program and project governance and enterprise risk management
• Advanced knowledge of automation and AI testing guard rails, including validation of ML models and automated testing pipelines
• Strong understanding of operations of functions

• Excellent communicator with the ability to translate technical and operational priorities into clear, actionable direction
• Distills complex issues into decision-ready narratives; frames options, risks, and recommendations to influence senior decisions.
• Ability to define and execute organizational strategy for validation operations across regions
• Demonstrated success managing large, varied perspectives, and geographically distributed teams
• Strong understanding of operational, financial, and compliance dimensions of global data delivery
• Capable of leading transformation initiatives and fostering innovation across complex organizations
• Leads through influence across functions/geographies; mentors global cohorts; provides structured feedback.
• Engages vendor, data, and industry forums; represents team professionally and credibly under pressure; maintains resilience and composure

• Business Savviness - Anticipates business and regulatory issues and shapes strategy accordingly; connects technical expertise to organizational and industry context to make strategic recommendations
• Influence - Leads large teams / projects, helps shape departmental strategy influences leaders, peers, and cross-functional partners to align on decisions and strategic direction
• Change Catalyst
• Drives improvements (e.g., organizational and cultural changes) with broader impact; demonstrates adaptability and ability to collaborate with others to make change successful; helps others overcome resistance to change

• Bachelor's Degree with a minimum of 10 year's experience working in relevant field for associated job description (related technical role), as well as:
• People management skills
• Demonstrated deep subject matter expertise in relevant discipline PMP, Change…