We are seeking a highly skilled and experienced Generative AI Business Enablement Lead to coordinate and drive a program of Generative AI capabilities across R&D with an initial focus on clinical and regulatory domains. This individual will be responsible for driving program activities (under the leadership of the R&D Business Transformation Lead), coordinating across internal teams and external vendors, and ensuring the successful delivery of innovative AI solutions that meet stakeholder requirements and regulatory standards. This role supports ongoing delivery, enhancement, and sustainment of GenAI modules (e.g., Paa (Protocol Authoring), CSRa (Clinical Study Report)), not just initial setup. Coordinate the execution and adoption of GenAI program and PoCs focused on R&D use cases. Owns delivery and sustainment of GenAI modules (starting with Paa) and will scale across the platform. Collaborate with project teams, clinical operations, regulatory affairs, IT, and external vendors to manage scope, requirements, and ensure success criteria. Ensure stakeholder feedback is captured and addressed during demos and functionality reviews. Translate stakeholder feedback into actionable requirements and enhancements. Manage to program timelines and budgets; ensure on-time and within-scope delivery. Proactively identify challenges, propose solutions, and manage risk throughout the project lifecycle. Partner closely with Organizational Change Management and Training staff to ensure understanding of changes and impacts to stakeholders. Oversee and guide business analyst and/or business support resources to ensure user interface consistency across deliveries. Prepare progress updates for senior leadership.
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Bachelors degree in Life Sciences, Computer Science, or a related field; advanced degree preferred.
10+ years of experience in pharmaceutical R&D, clinical development and/or regulatory affairs, with good understanding of the systems, processes, and compliance requirements supporting clinical trials and regulatory submissions.
Proven experience leading complex, cross-functional programs, ideally involving emerging technologies.
Familiarity with Generative AI tools, platforms, and implementation challenges in a regulated environment.
Experience with Agile or hybrid delivery methodologies is a plus.
Pharma R&D delivery, vendor management, cross-functional coordination.
Experience working with clinical systems (e.g., EDC, CTMS, eTMF) and regulatory platforms (e.g., RIM, eCTD)
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.