Job title: Technical Product Leader – Regulatory AI Innovation
Job Type: Full-time, Permanent
Location: London, UK – Hybrid/Remote
We're seeking a senior leader with a strong background in AI engineering and biopharma to drive the development, validation, and governance of AI-powered solutions within clinical development and regulated healthcare environments.
This is not a role for someone simply using AI tools. We're looking for an individual with hands-on experience building AI/ML systems, leading engineering teams, and translating cutting-edge AI into compliant, scalable products used in clinical trials and drug development.
Key Requirements:
- 10+ years' experience within biopharma, clinical trials, healthcare technology.
- Strong experience supporting Clinical Trial Applications (CTAs), drug development programmes, or GxP-regulated clinical environments.
- Experience leading senior discussions around business strategy for developing products and taking these products to health authorities.
- Confident in leading on a regulatory pathway and in negotiating with health authorities (EMA/FDA).
- Proven track record building and deploying AI/ML systems, including model development, validation, MLOps, and production deployment.
- Deep understanding of AI architecture, data pipelines, model governance, and software engineering best practices.
- Experience collaborating with cross-functional teams across Engineering, Data Science, Product, and Quality.
- Strong knowledge of QMS, Computer System Validation (CSV), GxP, GAMP 5, ICH-GCP, and 21 CFR Part 11.
- Familiarity with evolving AI regulations, including the EU AI Act and FDA/EMA guidance on AI.
Responsibilities:
- Lead the development and lifecycle management of AI-enabled products supporting clinical research and drug development.
- Establish frameworks for AI validation, governance, risk management, and regulatory compliance.
- Drive engineering excellence across AI/ML platforms, cloud infrastructure, and software delivery.
- Partner with Quality to ensure products meet global compliance requirements.
- Lead interactions with regulators and contribute to regulatory strategies for novel AI methodologies.
- Build scalable quality processes that enable innovation without compromising compliance.
Ideal Background:
We're particularly interested in candidates who combine:
- Biopharma / Clinical Development experience
- Strong AI engineering and coding foundations
- QMS and regulatory expertise
- Experience operating in highly regulated environments
This is a rare opportunity to shape the future of AI in drug development and clinical research, working at the forefront of technology, quality, and regulatory innovation.
For more information, please reach out to lucy.kirkaldy@cpl.com