Senior Principal Scientist / Associate Director, Toxicology
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
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