Senior Director, Global Clinical Operations and Medical Writing Technology

Vertex Inc.•Boston, MA

6d•Hybrid

About The Position

The Senior Director, Global Clinical Operations and Medical Writing Technology will lead a team responsible for planning, architecture, design, development, support, maintenance, and future roadmaps for systems supporting clinical operations and medical writing teams 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 deliver digital and Artificial Intelligence (AI) solutions in support of their goals and objectives.

Requirements

Direct experience with biotechnology and/or pharmaceutical systems, particularly in the areas of clinical operations and medical writing.
Hands-on expertise with identifying AI opportunities, deploying Agentic/Gen AI solutions, and leading/supporting AI focused organizational change management and training for business partners.
In-depth knowledge of the biotech industry, including specific regulations such as 21 CFR Part 11 and Good Clinical Practices (or other GxP areas).
Program/ project management, demand management, resource management and system life cycle expertise.
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.
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, enhancements, and operational support procedures.
In-depth experience in design, development, and deployment of technology solutions using agile software development practices.
IT financial management experience, managing budgets and forecasts across operational expenses and new investments.

Responsibilities

Partner with business stakeholders across Global Clinical Operations and Medical Writing teams to manage and prioritize the digital and AI technology 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 a regular basis.
Develop multi-year leadership-driven technology roadmaps delivering valued outcomes.
Direct and lead a group of 5 Vertex team members, plus a managed services team of support engineers, administrators, and analysts.
Oversee a portfolio of projects, programs, releases, and system enhancements, assuring quality and timeliness of delivery while remaining within allocated budget limits.
Proactively offer innovative new tools/technologies for consideration, AI solution 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, platform releases, and 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 as Veeva Vault Clinical Trial Management System (CTMS), Veeva Electronic Trial Master File (eTMF), and Elluminate Electronic Data Capture (EDC) platform, ensuring maximum uptime, high performance, and excellent customer service.
Work closely with Information Security and Quality Assurance groups as needed to ensure compliance with GxP regulations, as well as our DTE system lifecycle and change management requirements.