Clinical Pharmacology Domain Expert (Part-time Consulting)

Edison Scientific builds and deploys AI scientist agents to accelerate science and the development of new medicines. We are an ambitious team run by scientists and engineers from leading institutions across biology, physics, chemistry, and AI.

Responsibilities

• Knowledge sharing about "day-in-the-life" as an expert working with data in these domains to assemble regulatory submissions.

• Describing common tasks or problems where AI could be of value in your workflows.

• Identify + describe internal pharma systems that are commonly used for standard workflows.

• Generate or review reference ground-truth artifacts to evaluate against - reports, data files, modules, etc.

• Identify + add realistic sources of variance or data corruption in study data.

• Identify and correct discrepancies in data quality.

Qualifications

• 10+ years of experience in clinical pharmacology, preferably at a sponsor

• PhD, PharmD, or MD preferred

• Hands-on experience with exposure-response and population PK analyses included in regulatory submissions

• Experience authoring or reviewing clinical pharmacology sections of INDs, IBs, CSRs, and NDA/BLA modules

• Direct experience responding to regulatory agencies

• Enthusiastic about working with AI tools to evaluate and improve outputs

Why join us?

• Remote

• Flexible hours / flexible time zone

• This is an ad-hoc opportunity designed to fit around existing commitments. This engagement will likely be 5-20 hours per week and is ad-hoc in nature.

Note: Our consulting roles do not offer the benefits shared below.