Executive Director, Business Operations

Role Overview

• Oversees strategic business transformation efforts and coordinates the execution of cross-functional global business operations processes
• Enables the effective management of the Global Data Management & Standards (GDMS) organization in alignment with GDMS and broader organizational goals
• Sets the vision for the organization and establishes the global business operations framework
• 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
• Leads topic curation and orchestration of senior leadership team meetings and other GDMS forums including global townhalls and Data Management Center (DMC) site visits
• 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 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, Execution Excellence, Change Catalyst, Networking & Partnerships

Requirements

• Bachelor’s degree in life sciences, operations management, business analytics, or a related discipline
• Master’s degree in business, operations management, business analytics or a related discipline
• 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
• 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
• 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
• 7+ years proven track record directly managing stakeholder partnerships to enable successful operations delivery and support (ex. FSPs, technology, support services)
• 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)
• Strong analytical, problem-solving, and negotiation abilities with a pragmatic approach to balancing timelines, quality, and cost
• 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.

Tech Stack

• PMP

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days