Senior Director, Toxicology

Key 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.

People & Organizational Leadership

• 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.

Qualifications & Experience

• 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.
• Experience in therapeutic areas related to pain or neuroscience is preferred.

Core Competencies

• 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.

Pay

Negotiable based on experience and qualifications.

Schedule

Full-time position with flexible working hours to accommodate the needs of the role and the company.