Senior Principal Scientist / Associate Director, Toxicology
Job
Orum Therapeutics
Lexington, MA (In Person)
Full-Time
Review key factors to help you decide if the role fits your goals.
Pay Growth
?
out of 5
Not enough data
Not enough info to score pay or growth
Job Security
?
out of 5
Not enough data
Calculating job security score...
Total Score
79
out of 100
Average of individual scores
Skill Insights
Compare your current skills to what this opportunity needs—we'll show you what you already have and what could strengthen your application.
Job Description
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. Key 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.
Similar jobs in Lexington, MA
Roehl Transport
Lexington, MA
Posted1 day ago
Updated4 hours ago
Ingenovis Health
Lexington, MA
Posted1 day ago
Updated4 hours ago
Similar jobs in Massachusetts
MedPro Healthcare Allied Staffing
Boston, MA
Posted1 day ago
Updated4 hours ago
CONVENIENTMD
Pittsfield, MA
Posted1 day ago
Updated4 hours ago