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. 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. Technical skills 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 Qualifications & experience 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 clinicaltrialjobs EligibleforERP #GDMS Required 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 Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement 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. Learn more about your rights, including under California, Colorado and other US State Acts The salary range for this role is $173,200.00 - $272,600.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits. You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully 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. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: Yes Hazardous Material(s): No Job Posting End Date: 09/24/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.