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

• Educational Background: A degree in Life Sciences, Pharmacy, Medicine, or a related field is required. An advanced degree (Masters, PhD, PharmD) is highly preferred.

• Industry Experience: A minimum of 7-10 years of hands-on experience working within a pharmaceutical company or a CRO.

• Core Expertise: Proven, significant experience in the design and development of clinical trial protocols across different therapeutic areas and phases (Phase I-IV). Must have prepared and submitted clinical trial-enabling documents.

• Regulatory Knowledge: Deep understanding of the end-to-end clinical trial process, Good Clinical Practice (GCP), and international/local regulatory guidelines (e.g., ICH-GCP, FDA, EMA, CDSCO).

• Analytical Mindset: Strong analytical skills with the ability to deconstruct complex clinical processes into logical steps.

Desired Skills

• Passion for technology and innovation in the life sciences sector

• Familiarity with the software development lifecycle or experience working with technology teams is a huge plus.

• Exposure to or a keen interest in learning Artificial Intelligence, Machine Learning, and data analytics.

• Excellent communication and interpersonal skills, with the ability to articulate complex scientific concepts to a non-scientific audience.

• A proactive, problem-solving mindset and the ability to thrive in a fast-paced, collaborative startup environment.

Skills Required