Senior Director, Global Clinical Operations and Medical Writing Technology

General Summary:

The Senior Director, GlobalClinical Operations and Medical WritingTechnology will lead a team responsible for planning, architecture, design, development, support,maintenanceand future roadmaps for systems supportingclinical operations and medical writingteams at Vertex. The incumbent will collaborate with senior leaders and other key stakeholders across these areas of the business, as well as peers across the Data, Technology and Engineering (DTE) organization, to identify, prioritize, design and deliverdigital and Artificial Intelligence (AI)solutions in support of their goals and objectives.

Key Duties and Responsibilities:

• Partner with business stakeholders acrossGlobal Clinical Operations and Medical Writingteams to manage and prioritize thedigital and AItechnology portfolio and continually build the future roadmap
• Build and strengthen relationships with key stakeholders - become a trusted partner and have an ongoing, significant impact towards meeting strategic business goals
• Present ideas and forward-looking plans to, and engage directly with, cross-functional senior leaders on regular basis
• Develop multi-year leadership-driven technology roadmaps delivering valued outcomes
• Direct and lead a group of5Vertex team members, plus a managed services team of support engineers, administrators, and analysts
• Oversee a portfolio of projects, programs,releasesand system enhancements, assuring quality and timeliness of delivery whileremainingwithinallocatedbudget limits
• Proactively offer innovativenew tools/technologiesfor consideration, AIsolution ideas, and potential business process improvements in pursuit of driving efficiencies and meeting business needs
• Enhance and improve internal processes and procedures related to demand management, resource management, project delivery, platformreleasesand ongoing operational support
• Manage relationships with our strategic software vendors and service providers
• Provide day-to-day support and maintenance for business-critical applications such asVeevaVaultClinical Trial Management System (CTMS), VeevaElectronic Trial Master File (eTMF), andElluminateElectronic Data Capture (EDC)platform,ensuringmaximumuptime, high performance, and excellent customer service
• Work closely with Information Security and Quality Assurance groups as needed to ensure compliance withGxPregulations, as well as our DTE system lifecycle and change management requirements

Knowledge and Skills:

• Direct experience with biotechnology and/or pharmaceutical systems, particularly in the areas ofclinical operations and medical writing
• Hands-onexpertisewith identifying AI opportunities, deployingAgentic/Gen AIsolutions, andleading/supportingAI focusedorganizational change management and trainingfor business partners
• In-depth knowledge of the biotech industry, including specific regulations such as 21 CFR Part 11 and Good Clinical Practices (or otherGxPareas)
• Program/ project management, demand management, resourcemanagementand system life cycleexpertise
• Strong communication, interpersonal and collaborative skills
• Solid analytical and problem-solving abilities
• Excellent verbal, written, and presentation skills to influence technical and non-technical audiences

Education and Experience:

• Bachelor’s degree and 10+ years relevant work experience
• Biotech or pharmaceutical industry experience
• Experience managing implementation partners and managed services/ offshore teams
• Deep experience with enterprise applications and SaaS implementations, upgrades,enhancementsand operational support procedures
• In-depth experience in design, development, and deployment of technology solutions using agile software development practices
• ITfinancial managementexperience, managing budgets and forecasts across operational expenses and new investments

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