Toxicologist

Fantastic new opportunity for an experienced toxicologist at a brilliant biotech company!

My client is looking for a highly knowledgeable, competent and detail-oriented Toxicology Consultant with extensive responsibility for designing, monitoring and reporting results of in vitro and in vivo preclinical pharmacology and toxicology studies. Experienced author of INDs, NDAs, IBs, and SPA and CAC documents for regulatory submission.

Responsible for evaluating the effects of drugs and chemicals on animals and other test systems in compliance with strict GLP regulations.

Single point of contact and communication for study sponsors including US and international pharmaceutical, chemical, and government organizations.

Requirements:

Experience in cell and gene therapy and vaccine toxicity.

Expertise in GLP-Tox study about non-viral gene delivery nanoparticles analysis.

PhD in Pharmacology.

IND enabling study experience.

FDA experience preferred.

Responsibilities:

Responsible for planning, conducting and reporting regulatory-compliant IND-enabling studies such as dose-rangefinding, subchronic, chronic, carcinogenicity, biodistribution and other nonclinical studies.

Communicate study progress, results, and pertinent issues to sponsors succinctly and in real time.

Support clients with their drug discovery and development projects rapidly and within budget. Experience with small molecules, vaccines, cell and gene therapy.

Interviews are actively underway. Apply to learn more about this new opportunity.