Clinical Development & Operations Expert

Join a leading AI lab's cutting-edge GenAI team to be at the core of the AI revolution, where your expertise fuels the development of the most advanced Large Language Models.

1. Overview

Join a leading AI lab's cutting-edge GenAI team and help build foundational AI models from the ground up. We're seeking talented Clinical Development and Operations subject-matter experts (SMEs) from the pharmaceutical and biotech industry to bring deep expertise in clinical trial design and execution and elevate the quality of our AI training data. This is a full-time commitment of 40 hours per week.

This is a W-2 employment position with Cincinnatus LLC, with the opportunity to be placed at a leading AI Lab as part of their extended workforce.

2. Key Responsibilities

• Guide research and engineering teams to close knowledge gaps and improve AI model performance in clinical trial design, clinical operations, and GCP-compliant study conduct.
• Design challenging, realistic clinical development tasks, such as protocol design problems, endpoint and estimand choices, and enrollment and site performance scenarios, and write accurate, well-structured solutions.
• Evaluate AI model outputs on clinical development questions for accuracy against ICH E6 (GCP), E8 and E9 principles and real-world trial practice, and provide clear, written feedback.
• Develop guidelines and detailed rubrics to assess protocol design quality, feasibility reasoning, and risk-based monitoring decisions across tasks.
• Collaborate with other subject matter experts to ensure consistency and accuracy in training data.

3. Core Qualifications

• 7+ years of dedicated professional experience in Clinical Development or Clinical Operations within the pharmaceutical or biotech industry at a recognized, top-tier organization (e.g., a top-25 pharmaceutical company such as Pfizer, Merck, Roche, Novartis, AstraZeneca, Johnson & Johnson, AbbVie, Eli Lilly, Bristol Myers Squibb, Sanofi or GSK; a major biotech such as Amgen, Gilead, Genentech, Regeneron, Vertex or Biogen; a leading CRO such as IQVIA, ICON, Parexel, Syneos Health, PPD/Thermo Fisher, Labcorp/Fortrea or Medpace; or a regulator such as the FDA or EMA).
• Hands-on experience designing or running Phase I to III interventional trials, including protocol development, study start-up, site and CRO or vendor management, and study close-out.
• Working knowledge of ICH GCP (E6), trial design and statistical principles (E8, E9), and core systems such as CTMS, EDC and eTMF.
• Current or most recent role at Senior Manager or Associate Director level or above, with demonstrable career progression (e.g., Clinical Trial Manager → Senior Clinical Trial Manager → Associate Director, Clinical Operations → Director, or Clinical Scientist → Senior Clinical Scientist → Associate Director, Clinical Development).
• Ability to engage reliably for at least 40 hours/week during weekdays.
• Experience with AI training or evaluation work, or hands-on use of AI tools in clinical development work, is a plus.
• Strong written communication skills and the ability to explain complex trial design decisions clearly.

About Cincinnatus LLC: Cincinnatus LLC is an enterprise staffing company that partners with leading technology companies to source and employ highly skilled professionals for contingent and contract-based opportunities. Cincinnatus serves as the employer of record for these engagements, providing W-2 employment, payroll, benefits, and compliance, while placing employees directly within client teams to work on high-impact initiatives.

Equal Employment Opportunity: Cincinnatus is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, reproductive health decisions, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetic information, political views or activity, or any other legally protected characteristic.