Clinical Trials Specialist / Product Leader

Job Description

Job Summary

We are seeking a highly experienced Clinical Trials Specialist with a background in pharmaceuticals or a Contract Research Organization (CRO) to join our product development team. This is a unique opportunity to step out of the traditional clinical operations role and apply your deep domain expertise to shape the next generation of clinical trial software. You will serve as the subject matter expert, ensuring our AI platforms are built on a solid foundation of real-world clinical research principles and address the most pressing challenges in trial design and execution.

Key Responsibilities

• Subject Matter Expertise : Act as the primary internal consultant on all aspects of clinical trial design, planning, and protocol development.
• Product Development Collaboration : Work closely with software engineers, data scientists, and product managers to translate complex clinical trial concepts into functional software requirements and AI model features.
• Protocol & Design Input : Provide expert review and guidance on trial protocols, study designs (e.g., adaptive trials, decentralized trials, basket trials), and endpoint selection to inform the logic to automate the workflows of our platforms.
• Feature Validation : Test and validate new software features and AI-driven recommendations to ensure they are clinically sound, compliant, and user-friendly for research professionals.
• Content & Algorithm Curation : Assist in curating, extracting and, structuring clinical data from scientific literature, and regulatory guidelines to train and refine our AI models.
• Market & User Insights : Stay abreast of industry trends, regulatory changes (e.g., ICH, CDSCO), and the evolving needs of clinical research professionals to guide product strategy.

Requirements

Required Qualifications & Experience

Desired Skills

Requirements