Elaine V. Knight Email & Phone Number

Pennsylvania, United States

Direct support of Drug Discover and Drug Development projects.Responsible for independently preparing non-clinical development plans including necessary studies and their timing for small molecule therapeutics.Develop toxicology study designs for testing drug candidates from early discovery to IND filing. Interact with the scientific staff within drug development teams on general matters pertaining to toxicology, represent Toxicology and Pharmacology Branch (TPB) during discussions with regulatory agencies. interface with Chemists, Biologists and other laboratory scientists as required, to provide technical leadership on research activities.Effectively communicate the relevance and interpretation of study and experimental findings to senior management, represent a non-clinical drug safety evaluation function on multiple project teams, compose and edit relevant sections of regulatory and scientific documents, and provide technical expertise to support project team goals and objectives.

ECKnight Consulting Services, LLC is a specialized consulting company serving the pharmaceutical and chemical industry in the areas of nonclinical development and safety assessment. We have more than 20 years experience with small molecule and biologic drug development, and safety and risk assessment. We have extensive expertise in every phase of the nonclinical drug development process.

Responsible for providing strategic scientific advice on nonclinical solutions. Manage interactions with Biopharma and Consumer Clients. Define roadmap for scientific search and discovery.Regulatory interactions and participation in CDISC SEND initiatives.

• Preclinical Toxicology Lead Scientist on the evaluation of nonclinical drug safety in multiple therapeutic areas. • Served as Toxicology lead expert for Preclinical Development on assigned projects. As Study Director, and Study Monitor for the design and conduct and reported over 600 toxicology studies of all types and duration (acute, subchronic, chronic, carcinogenicity, and special toxicity). Understands regulatory guidelines compliant with working knowledge of GLPS and current technology that contributed to the project teams’ deliverables.• Designed toxicology programs, provided functional expertise for drug development teams, and prepared presentations for management. Actively engaged in scientific discussions on study or project issues.