Immunome, Inc.
Director, Toxicology
Bothell, Washington, United States · Director
Sponsorship not specifiedDetected 1 day ago
Code ReviewPharmacologyFDA RegulatoryResearchLeadershipRegulatory Affairs
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16Unrated
Cap-exempt (no lottery)0
Sponsors this role0
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
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About the role
- Position Overview The Director, Toxicology provides scientific and strategic leadership for the nonclinical safety assessment of oncology therapeutics from discovery through commercialization.
- The successful candidate combines deep scientific expertise with strategic judgment to identify and mitigate development risks while advancing innovative oncology therapeutics.
- Cross-Functional Leadership - <span data-cont
Responsibilities
- Serve as the nonclinical safety lead for multiple oncology development programs from candidate selection through regulatory approval.
- Develop integrated, phase-appropriate nonclinical safety strategies that support efficient clinical development while meeting global regulatory expectations.
- Provide scientific leadership on target-, platform-, and modality-related safety risks and develop mitigation strategies.
- Lead interpretation of complex toxicology findings and translate results into actionable recommendations for project teams and executive leadership.
- Design nonclinical development plans supporting INDs, CTAs, NDAs, BLAs, and global regulatory interactions.
- Design, oversee, and interpret GLP and non-GLP toxicology studies conducted at external CROs.
- Manage CRO performance, timelines, budgets, and scientific deliverables.
- Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies.
Benefits
- Integrate toxicology, pharmacology, DMPK, pathology, biomarker, and clinical data into comprehensive benefit-risk assessments.
- Represent Toxicology during FDA, EMA, PMDA, and other global health authority interactions.
Company info
- We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.
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