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

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.

2. Operational Governance & Leadership Enablement * 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.

3. Portfolio, Demand & Capacity Management * 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.

4. Performance, Metrics & Business Insights * 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.

5. Operational Excellence & Continuous Improvement * 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

Non-technical skills

• 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

Enterprise Leadership Skills

• 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 management and communication

OR

• Advanced Degree (Masters or Doctorate) with a minimum of 8 year’s experience working in relevant field for associated job description, as well as:
• People management skills, Adaptability, Business Agility, Business Decisions, Business Process Improvements, Change Management, Clinical Data Management, Decision Making, Enterprise Leadership, Good Clinical Practice (GCP), Organizational Leadership, Planning, Situational Leadership, Stakeholder Management, Strategic Leadership, Strategic Planning, Strategy Deployment

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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The salary range for this role is

$173,200.00 - $272,600.00

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.