Director, Technology Product Group Leader – Submission Excellence

Responsibilities

• Collaborate with the IM R&D Business and J&J Technology partners to develop, refine, and execute a technology vision and strategy that aligns with the overall program objectives.
• Understand and leverage emerging generative AI technologies to support submission acceleration and regulatory strategy.
• Design and implement AI technologies that streamline regulatory document workflows and health authority query response generation.
• Lead the creation of AI-ready data packages for downstream tools and applications.
• Support the adoption of new technologies among global regulatory teams to drive productivity.
• Lead the design, engineering, and operationalization of advanced AI products and solutions, ensuring scalable and seamless integration across the organization.
• Collaborate with Enterprise AI Technology Teams to drive capability requirements, governance alignment, system maturity and benchmarking.
• Establish and maintain strong relationships with internal and external stakeholders, including external vendors & partners.
• Implement and evolve AI governance practices and policies, ensuring compliance with regulatory and ethical standards.
• Prepare executive-ready status, dashboards, investment cases, CARs, and leadership presentations; ensuring clear storytelling of value, risks, and decisions.
• Co-Lead the decision-making process for AI architecture, platform selection, and build/buy/blend strategies in collaboration with the business leaders.
• Support the development and implementation of responsible AI practices, ensuring data privacy, model explainability, fairness, and ethical use of AI technologies.
• Mentor and lead multidisciplinary AI and technology product teams, fostering a culture of innovation, agility, and continuous improvement.

• A minimum of a Bachelor's degree in a scientific, technical, or Information Technology related field is required.
• 10+ years in technical product development roles, with 3-5+ years of experience leading technical product teams.
• Strong understanding of global regulatory submission processes (e.g., FDA, EMA, PMDA) and compliance requirements.
• Deep understanding of R&D business objectives, industry domain, and the transformative potential of AI for R&D business models, workflows, and operations.
• Proven expertise in AI-driven technology transformation, including decision intelligence, agentic AI, and other transformative approaches.
• Comprehensive knowledge of regulatory and compliance frameworks relevant to AI and data protection.
• Demonstrated ability to build, lead, and motivate high-performing teams in dynamic, multidisciplinary environments.
• Ability to define the process and tracking TCO of the AI solutions and services.

• AI technologies
• regulatory document workflows
• data privacy
• model explainability
• decision intelligence
• agentic AI
• AI architecture
• AI governance practices
• technical product development
• TCO tracking

• collaboration
• leadership
• mentoring
• storytelling
• relationship building
• innovation
• agility
• continuous improvement
• team motivation
• communication