Director, Preclinical Safety

About the role

The Director, Preclinical Safety will shape and lead the non‑clinical safety strategy for a growing portfolio of early‑stage biotech assets. Reporting to senior leadership, this role translates complex biology into a coherent safety framework that supports progression from discovery through IND filing and beyond.

Key responsibilities

• Architect and implement integrated preclinical safety strategies aligned with program milestones.
• Design, oversee, and interpret toxicology and safety pharmacology studies using internal resources and external CROs.
• Establish and manage a high‑performing CRO network, including selection, qualification, and ongoing oversight.
• Lead nonclinical safety components of regulatory submissions, authoring IND packages and providing strategic input.
• Identify emerging safety signals and translate data into actionable risk assessments.
• Partner cross‑functionally with biology, clinical, and regulatory teams to ensure integrated decision‑making.
• Serve as a scientific leader and mentor, elevating rigor and capability as the organization scales.

Required profile

• DVM, Ph.D. or equivalent with board certification in a relevant field (e.g., ACVP).
• 10‑15+ years of experience leading preclinical safety strategy for IND‑enabling programs.
• Proven track record supporting regulatory submissions (IND and beyond).
• Experience managing multiple programs in parallel while balancing speed and scientific rigor.
• Strong external orientation with experience overseeing CRO relationships.

Required skills

• Toxicology study design, execution, and interpretation.
• Safety pharmacology study design and data analysis.
• IND regulatory submission preparation.
• CRO selection, qualification, and oversight.
• Risk assessment and safety signal evaluation.
• Nonclinical safety strategy development.