Senior Principal Scientist / Associate Director, Toxicology

Orum Therapeutics•Lexington, MA

30d•Hybrid

About The Position

We are seeking a highly experienced toxicology scientist to support and drive nonclinical safety strategies for Degrader-Antibody Conjugate (DAC) programs. This role is centered on hands-on toxicology, including study design, execution, and data interpretation. The successful candidate will contribute to the advancement of DAC candidates from discovery through IND-enabling studies and regulatory submissions, operating at the Senior Principal Scientist / Associate Director level and working cross-functionally with research, DMPK, CMC, and regulatory teams.

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.

Nice To Haves

Prefer DABT certified but not required.
Prior experience with targeted protein degradation or other emerging modalities.
Experience participating in regulatory agency interactions

Responsibilities

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.
Serve as the nonclinical toxicology representative in regulatory interactions (e.g., FDA), including preparation of responses to regulatory questions.
Ensure nonclinical programs align with global regulatory expectations and guidelines.
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.
Contribute scientific input to programs involving targeted protein degradation (e.g., PROTACs, molecular glues, or DACs), primarily from a nonclinical safety perspective.
Stay current with evolving nonclinical strategies for emerging therapeutic modalities.