
Privacy Policy
Job Openings
Senior Director, Toxicology
Lead the overall nonclinical safety and toxicology strategy from early discovery through IND submission, clinical development, and NDA submission.
Serve as the toxicology and nonclinical safety SME on cross‑functional project teams, providing clear risk–benefit assessments and strategic recommendations.
Design, oversee, and interpret IND‑enabling toxicology and safety pharmacology studies, ensuring alignment with regulatory expectations and development timelines.
Provide scientific oversight of CROs, consultants, and vendors, including study design, protocol review, data quality, and final report approval.
Partner closely with Regulatory Affairs to author, review, and approve nonclinical sections of INDs, IBs, briefing documents, and regulatory responses.
Support regulatory interactions (FDA and ex-US), including pre-IND, end-of-Phase 2, pre-NDA, and other regulatory meetings.
Build, mentor, and develop a high‑performing nonclinical safety team, fostering scientific excellence and collaborative culture.
Contribute to the evolution of nonclinical processes, standards, and best practices as the organization scales.
PhD, DVM, or equivalent in Toxicology, Pharmacology, or a related scientific discipline.
15+ years of industry experience in nonclinical safety/toxicology within biotechnology or pharmaceutical settings.
Demonstrated leadership of toxicology programs for small molecule therapeutics from IND-enabling studies through marketing applications
Strong track record of regulatory authorship and agency interactions supporting early development programs.
Proven ability to lead cross‑functional teams and influence development strategy at the program and portfolio level.
Deep scientific expertise in nonclinical safety and toxicology
Strategic thinking with strong execution focus
Clear, persuasive scientific communication
Collaborative leadership and people development
Comfort operating in a fast‑paced, early‑stage biotech environment
Apply for This Job
Privacy Policy
•
Terms of Service
© BambooHR All rights reserved.
Originally posted by Latigo Biotherapeutics. View original posting
BioCareerAI is an independent job platform and is not affiliated with or endorsed by Latigo Biotherapeutics.
