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Senior Principal Scientist / Associate Director, Toxicology

Remote, USA Full-time Posted 2025-11-24
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. 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. 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 Apply tot his job Apply To this Job

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