Research Scientist RN at Providence assuming responsibilities in leading research studies and innovative educational programs. Focusing on quality improvement and dissemination of study results in healthcare.
About the role
- Senior Principal Scientist driving nonclinical safety strategies for Degrader-Antibody Conjugate programs at Orum Therapeutics. Overseeing nonclinical toxicology studies and collaborating with cross-functional teams.
Responsibilities
- Design, oversee, and interpret IND-enabling nonclinical toxicology studies for DAC programs.
- 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 close 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.
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