Associate Director, Nonclinical Writing AI Innovation

Overview

The Associate Director, Nonclinical Writing Innovation, will lead the strategy and adoption of AI-enabled capabilities across nonclinical workflows. This high-visibility role will translate organizational priorities into scalable digital solutions that improve productivity and efficiencies, while maintaining data integrity, and life-cycle management from data generation through regulatory documentation. The position will include, but not limited to, AI tool automation, authoring regulatory dossiers, reporting, data integrity, record retention, and Training / SOP Management.

The role partners cross-functionally with scientific, technology, quality, regulatory, and business stakeholders to identify high-value use cases, operationalize AI tools, and build responsible, sustainable AI practices.

Hybrid role based in Cambridge, MA, with onsite presence aligned to team and business needs.

• Lead intake, prioritization, and ROI tracking for AI use cases that improve productivity and operational efficiencies.
• Partner with scientific, regulatory, quality, IT, Info Sec, legal, procurement, and business teams to pilot, deploy, and scale AI-enabled solutions.
• Accountable for nonclinical writing deliverables across many programs to improve data verification, quality, and authoring regulatory documents using AI tools.
• Define and execute an AI strategy and roadmap aligned with Early Development, Nonclinical Writing, and organizational innovation priorities.
• Champion adoption of AI, automation, and digital enablement approaches across workflows, including governance, quality control, reporting, regulatory dossiers, training, and knowledge management.
• Evaluate emerging technologies, enterprise AI platforms, and vendor solutions to support responsible, secure, and fit-for-purpose implementation.
• Establish best practices to increase productivity, data quality, reproducibility, responsible AI use, and compliance with applicable regulatory and GXP expectations.
• Build AI capability through training, coaching, change-champion networks, and executive-ready communications that support sustainable adoption.

• Bachelor's degree in a relevant scientific field required;
  Master's or PhD preferred.
• Approximately 5-10 years of progressive experience in AI, digital transformation, technology enablement, computational life sciences, nonclinical regulatory writing, contract research organization (CRO), or related R&D environments.
• Demonstrated expertise in authoring a wide range of regulatory documents (eg, nonclinical study protocols and reports, IBs, regulatory submissions).
• Demonstrated experience translating scientific or business needs into scalable AI-enabled solutions, including use case prioritization, implementation, adoption, and value measurement.
• Hands-on fluency with leading AI and LLM platforms, automation capabilities, agentic AI concepts, low-code prototyping, and responsible human-in-the-loop deployment models.
• Strong understanding of life sciences, R&D, nonclinical electronic data systems, program management solutions, regulatory documentation workflows, and regulated or IP-sensitive operating environments.
• Proven ability to lead complex cross-functional initiatives without direct authority and communicate effectively with technical, scientific, operational, and senior leadership audiences.
• Preferred experience with enterprise AI tools, data architecture or cloud platforms, AI governance frameworks, vendor management, consulting, or change management programs.
• Knowledge and understanding of global health authority requirements preferred, including but not limited to, CDER/CBER, OECD, ICH guidelines, and eCTD submission requirements, and Standard for Exchange of Nonclinical Data (SEND).

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The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).

Alnylam's robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k) with a generous company…