Design, oversee, and interpret IND-enabling nonclinical toxicology studies for DAC programs, including GLP toxicology, safety pharmacology, and toxicokinetic assessments.
Serve as the nonclinical toxicology lead on assigned DAC programs, providing scientific input on nonclinical safety assessment, risk identification, and mitigation strategies.
Support clinical starting dose selection and risk assessment in collaboration with DMPK and clinical development teams.
Author and contribute to nonclinical sections of INDs and related regulatory documents.
Collaborate closely with pharmacology, DMPK, pathology, bioanalytical, CMC, regulatory affairs, and clinical development teams.
Manage external CROs and consultants, ensuring scientific quality, timelines, and budget adherence.

Requirements

PhD in Toxicology, Pharmacology, Biology, or a related discipline.
Minimum of 5 years of relevant industry experience in nonclinical drug development.
Demonstrated experience leading IND-enabling toxicology programs and supporting successful IND submissions.
Strong hands-on and/or strategic experience with ADC-based molecules (ADC or DAC) is required.
Experience managing CROs and working effectively in cross-functional teams.
Prefer DABT certified but not required.
Prior experience with targeted protein degradation or other emerging modalities.
Experience participating in regulatory agency interactions.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

toxicologysafety pharmacologytoxicokineticsIND submissionsADC-based moleculestargeted protein degradationnonclinical drug developmentrisk assessmentscientific quality managementcross-functional team collaboration

Soft Skills

leadershipscientific inputrisk identificationmitigation strategiescollaborationcommunicationproject managementbudget adherenceproblem-solvingstrategic thinking

Certifications

PhD in ToxicologyPhD in PharmacologyPhD in BiologyDABT certification