Toxicologist Consultant (ADC Project)

Location: Remote, US
Contract Type: Part-Time, Contract

Job Overview

We are seeking a Part-Time Toxicologist to support early-stage toxicology studies for a Contract Research Organization (CRO) client. This role will focus on non-GLP exploratory studies to assess the safety profile of a targeted peptide conjugated to MMAE (Monomethyl Auristatin E). The studies will include pharmacokinetics (PK) and toxicology evaluations, primarily utilizing rats and monkeys as test species.

The ideal candidate will have hands-on experience with MMAE cytotoxin conjugates, along with expertise in early toxicology study design, execution, and interpretation of results. This role is crucial for guiding the sponsor in understanding the compound’s safety profile before advancing to regulated studies.

Key Responsibilities

• Design and oversee early-stage toxicology studies, focusing on the safety and PK of an MMAE-conjugated peptide.

• Provide scientific input on study protocols, dosing regimens, and species selection (rats and monkeys).

• Analyze and interpret pharmacokinetics (PK) and toxicology data, providing insights into potential safety concerns.

• Guide study execution, ensuring best practices in toxicology assessment despite the non-GLP setting.

• Collaborate closely with the CRO team and sponsor, offering expert recommendations based on experience with MMAE cytotoxin conjugates.

• Support the preparation of study reports and presentations to communicate findings effectively.

Qualifications & Experience

• Advanced degree (Ph.D. or D.V.M.) in toxicology, pharmacology, or a related field.

• Minimum 5 years of experience in preclinical toxicology studies, particularly with MMAE cytotoxin conjugates.

• Expertise in early toxicology, exploratory studies, and PK assessments.

• Experience working with rodent and non-human primate (NHP) models in a toxicology setting.

• Strong understanding of non-GLP study design and how early findings translate into later-stage regulatory work.

• Ability to interpret and communicate complex toxicology data to multidisciplinary teams.

• Prior experience collaborating with CROs and biopharma sponsors is a plus.

This role is an excellent opportunity for a toxicologist with MMAE-conjugate experience to play a critical role in shaping early drug development decisions.