Overview
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
Nonclinical Toxicology
- 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.
IND and Regulatory Responsibilities
- 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.
Cross-Functional Collaboration
- 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.
Emerging Modalities (Plus)
- 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.
Qualifications
Education
- PhD in Toxicology, Pharmacology, Biology, or a related discipline.
Experience
- 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.
Preferred Qualifications
- Prefer DABT certified but not required.
- Prior experience with targeted protein degradation or other emerging modalities.
- Experience participating in regulatory agency interactions
*U.S. citizens and those authorized to work in the U.S. (green card) are encouraged to apply. We are unable to sponsor/transfer at this time.
*Candidate must be able to pass a background investigation.
*Unable to work with 3rd party candidates or agencies.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above. Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position’s essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Orum Therapeutics is an Equal Opportunity Employer (EOE).
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