Executive Director, Business Operations

Merck•Rahway, NJ

1d•Hybrid

About The Position

The Executive Director, Business Operations oversees strategic business transformation efforts and coordinates the execution of cross-functional global business operations processes to enable the effective management of the Global Data Management & Standards (GDMS) organization in alignment with GDMS and broader organizational goals. Under the direction of the Head of GDMS, the Executive Director sets the vision for the organization and establishes the global business operations framework. In partnership with the GDMS senior leadership team and organizational stakeholders, coordinates delivery of services including headcount management; resource forecasting and algorithm management; budget and expense management; financial forecasting; operations reviews; strategic project coordination; change management; communications; and professional development. Additional responsibilities of the Head of Business Operations include: Leads topic curation and orchestration of senior leadership team meetings and other GDMS forums including global townhalls and Data Management Center (DMC) site visits, ensuring strategic relevance, engagement, and productive outcomes Serves as a cross-functional integrator, ensuring tracking and status reporting for GDMS objectives to drive alignment, risk management, and execution against strategic priorities Maintains and facilitates the reporting of GDMS Key Performance Indicators (KPI) and Key Quality Indicators (KQI) as part of formal operations reviews Develops of strategies to enhance organizational value and efficiency Leads talent development and performance management activities for Business Operations with a focus on building a high-performing team and fostering a culture of growth and development Proactively engages with stakeholders to identify opportunities for innovation and continuous improvement Sponsors and/or leads organizational initiatives Enterprise Leadership Skills – behaviors and impact expected in this role include: Strategic Planning: Thinks strategically and gains alignment through collaborative stakeholder engagement and influence across development, clinical operations, support functions, and IT Execution Excellence: Drives reliable, high‑quality delivery by establishing end‑to‑end processes and data driven measurement approaches to track progress and effectiveness of outcomes Change Catalyst: Sponsors and drives change. Energizes teams through clear, compelling communication at all levels. Networking & Partnerships: Proactively builds and sustains strategic internal and external relationships (cross‑functional leaders, stakeholders, technology vendors, and service suppliers)

Requirements

Clinical Data Management & Operations Experience: 15+ years in clinical data management and operations within the pharmaceutical or biotech industry with Bachelor’s degree, or 13+ years with Master’s degree
Organization Leadership & Management Experience: 10+ years in progressive leadership roles managing operations in clinical data management or clinical operations functions, including resourcing and budget management
10+ years of experience and demonstrated success in personnel management, including direct line management of managers and functional leaders in a matrixed, global organization
Stakeholder Management Experience: 7+ years proven track record directly managing stakeholder partnerships to enable successful operations delivery and support (ex. FSPs, technology, support services)
Process Design & Implementation Experience: Demonstrated experience designing and implementing cross-functional, global operational processes and frameworks
Knowledge of full CDM lifecycle: data collection and validation design, data capture, data cleaning and reconciliation, database lock, and study close out
Familiarity with applicable regulations (ICH E6 R3, 21 CFR Part 11)
Ability to translate strategy into scalable, global, operational frameworks and processes
Strong analytical, problem-solving, and negotiation abilities with a pragmatic approach to balancing timelines, quality, and cost
High integrity and a compliance-focused mindset
Ability to convert complex technical concepts into clear, concise, and actionable communications for nontechnical executives and cross-functional stakeholders.
Outstanding written and verbal communication skills that can be deployed across all levels of the organization
Budget Management
Business Operations
Clinical Data Management
Clinical Data Standards
Clinical Operations
Continuous Improvement
Cross-Functional Teamwork
Executive Leadership
Matrix Leadership
Project Management
Regulatory Governance
Risk Management
Strategic Leadership
Strategic Management
Strategic Planning

Nice To Haves

Advanced training or certification in clinical research and/or data management relevant disciplines including, but not limited to: Association of Clinical Research Professional (ACRP) certification; SCDM Clinical Data Manager (CCDM) certification; Lean Six Sigma; or Project Management Professional (PMP) certification

Responsibilities

Leads topic curation and orchestration of senior leadership team meetings and other GDMS forums including global townhalls and Data Management Center (DMC) site visits, ensuring strategic relevance, engagement, and productive outcomes
Serves as a cross-functional integrator, ensuring tracking and status reporting for GDMS objectives to drive alignment, risk management, and execution against strategic priorities
Maintains and facilitates the reporting of GDMS Key Performance Indicators (KPI) and Key Quality Indicators (KQI) as part of formal operations reviews
Develops of strategies to enhance organizational value and efficiency
Leads talent development and performance management activities for Business Operations with a focus on building a high-performing team and fostering a culture of growth and development
Proactively engages with stakeholders to identify opportunities for innovation and continuous improvement
Sponsors and/or leads organizational initiatives