Senior Director, Toxicology
About the position
The Senior Director of Toxicology will provide strategic and scientific leadership for all aspects of nonclinical safety and toxicology across Latigo’s discovery and development pipeline. This role is accountable for defining and executing phase-appropriate nonclinical safety strategies to support candidate selection, IND-enabling activities, first-in-human (FIH) studies, and overall clinical development for small molecule programs.
As a recognized subject matter expert, the Senior Director will serve as a core member of cross‑functional project teams and a key contributor to regulatory strategy. This individual will oversee internal and external toxicology resources, mentor and develop nonclinical scientists, and ensure high scientific rigor, regulatory compliance, and efficient execution of nonclinical safety programs.
Responsibilities
• 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.
• Define target safety profiles and guide compound progression decisions in partnership with Discovery, DMPK, Clinical Pharmacology, and Clinical Development teams.
• 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.
• Ensure nonclinical safety and toxicology programs are scientifically sound, efficiently executed, and appropriately staged for development phase.
• 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.
• Ensure compliance with GLP, ICH, and FDA regulatory guidance applicable to nonclinical safety.
• 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.
• Act as a thought partner to senior R&D leadership on portfolio strategy and organizational capability development.
Requirements
• 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
Nice-to-haves
• Experience in therapeutic areas related to pain or neuroscience is preferred.
Apply tot his job
Apply To this Job
The Senior Director of Toxicology will provide strategic and scientific leadership for all aspects of nonclinical safety and toxicology across Latigo’s discovery and development pipeline. This role is accountable for defining and executing phase-appropriate nonclinical safety strategies to support candidate selection, IND-enabling activities, first-in-human (FIH) studies, and overall clinical development for small molecule programs.
As a recognized subject matter expert, the Senior Director will serve as a core member of cross‑functional project teams and a key contributor to regulatory strategy. This individual will oversee internal and external toxicology resources, mentor and develop nonclinical scientists, and ensure high scientific rigor, regulatory compliance, and efficient execution of nonclinical safety programs.
Responsibilities
• 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.
• Define target safety profiles and guide compound progression decisions in partnership with Discovery, DMPK, Clinical Pharmacology, and Clinical Development teams.
• 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.
• Ensure nonclinical safety and toxicology programs are scientifically sound, efficiently executed, and appropriately staged for development phase.
• 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.
• Ensure compliance with GLP, ICH, and FDA regulatory guidance applicable to nonclinical safety.
• 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.
• Act as a thought partner to senior R&D leadership on portfolio strategy and organizational capability development.
Requirements
• 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
Nice-to-haves
• Experience in therapeutic areas related to pain or neuroscience is preferred.
Apply tot his job
Apply To this Job