Nonclinical Study/Program Management:
Design, write, review, and monitor nonclinical pharmacology, ADME, and toxicology study protocols for drugs, biologics, devices, or combination products. Act as nonclinical expert in projects and interact with subcontractor for nonclinical studies/programs. Write and review nonclinical study reports. Conduct nonclinical data assessment and literature review.
Contribute to strategic discussions and associated documents/reports regarding drug, biologic, or device development issues with primary emphasis on nonclinical aspects. Assist in the evaluation of potential technologies and preparation of business development proposals with primary emphasis on nonclinical aspects. Act as a nonclinical expert on project teams for Sponsors and regulatory agency meetings.
Assist in the development and management of projects.
· Requires a Ph.D. or equivalent degree in toxicology or related field.
· Minimum of 1 to 3 years of experience in toxicology or related area.
· Requires experience as Study Director in a toxicology laboratory or equivalent qualification.
· High proficiency in toxicology study design, data interpretation, and nonclinical safety development.
· Scientific and regulatory toxicology knowledge of drug, biologic, and device development.
· Strong written and communication skills in English.
· Ability to work under pressure, adjust to changing priorities, and meet urgent deadlines.
· Critical thinking and analytical skills
· Proficient in MS Office.