AI Governance as Competitive Capability: Constructing and Empirically Validating a Maturity Index for Biopharma Firms

The integration of Artificial Intelligence (AI) is rapidly transforming the biopharmaceutical industry, promising to accelerate drug discovery, enhance clinical trials, and optimize manufacturing. However, the absence of a standardized framework to measure AI governance maturity and link it to tangible business outcomes hinders firms from realizing its full competitive potential. This paper addresses this gap by constructing a comprehensive AI governance maturity index tailored specifically for the biopharma sector. Through a synthesis of regulatory guidance, industry case studies, and academic literature, the proposed index is built upon five foundational pillars: Strategy and Accountability; Risk Management and Compliance; Data Governance; AI Lifecycle and Responsible Principles; and People, Technology, and Culture. Recognizing the sector's heterogeneity, the index is segmented to address the distinct strategic priorities and operational realities of Large Pharmaceutical Corporations, Small-to-Medium-Sized Biotechnology Companies (SMEs), and Contract Research Organizations (CROs). The findings establish that mature AI governance is not merely a compliance function but a strategic capability that directly drives key performance outcomes, including accelerated speed-to-market and enhanced return on investment. This index provides a practical tool for firms to benchmark their capabilities, guide strategic investments, and ultimately leverage AI governance as a durable source of competitive advantage.