Assist with assay development, conduct, and interpretation during lead optimization 

Conduct literature searches and summarize data pertinent to research/development programs

Perform nonclinical due diligence for potential inlicensed programs 

Provide a comprehensive nonclinical IND-enabling plan for small molecule or biopharmaceutical programs

Provide team leadership and project management for the nonclinical aspects of drug development programs 

Identify cost-effective toxicology contract research organizations (CROs) for nonclinical Tox/Pharm/ADME studies, write protocols, monitor study conduct, ensure GLP compliance and deliver quality data and reports

Write the nonclinical sections of INDs and marketing applications 

Provide nonclinical regulatory advice, and represent the client at regulatory agency meetings and telecons, respond to any nonclinical regulatory issues 

Identify and convene scientific experts, and other drug development consultants, when needed 

Write regulatory agency submission quality reports with data provided from the client’s lab or a CRO 

Write publication quality manuscripts for research and development  

Conduct on site training and/or seminars on nonclinical drug development