Director, Preclinical Safety

We are partnering with a well-capitalized, stealth-stage biotechnology company that is building a differentiated therapeutic platform with the potential to address significant unmet needs. Backed by experienced leadership and institutional-grade investors, the company is advancing its programs toward IND with a deliberate, milestone-driven strategy.

About the role

At this critical stage, the organization is seeking a Director of Preclinical Safety to architect and lead the nonclinical safety strategy across a growing portfolio of assets. This is a foundational role designed for a leader who can translate complex biology into a coherent safety framework, enabling confident progression from discovery through IND and beyond. The successful candidate will be a leader who brings both depth in toxicology and the judgment required to operate effectively in an early-stage, high-ambiguity environment.

The Company is primarily an on-site organization that fosters a collaborative, culture-driven workplace and embraces flexibility when needed to support its employees.

Responsibilities

• Architect and implement integrated preclinical safety strategies aligned to program-specific and portfolio-level development milestones.
• Design, oversee, and interpret toxicology and safety pharmacology studies, leveraging both internal capabilities and external CRO partnerships.
• Establish and manage a high-performing external network, including CRO selection, qualification, and ongoing oversight to ensure data integrity and regulatory compliance.
• Lead the nonclinical safety components of regulatory submissions, including authorship and strategic input for INDs and future filings.
• Identify and contextualize emerging safety signals, translating data into actionable risk assessments that inform program direction.
• Partner cross-functionally with biology, clinical, and regulatory teams to ensure integrated decision-making across the development continuum.
• Serve as a scientific leader and mentor, elevating rigor and capability across the organization as the team scales.

Requirements

• DVM, Ph.D. or equivalent with board certification in a relevant field like veterinary pathology (ACVP).
• 10-15+ years of experience leading preclinical safety strategy for IND-enabling programs.
• Deep expertise in toxicology and safety pharmacology study design, execution, and interpretation.
• Proven track record supporting regulatory submissions (IND and beyond).
• Experience managing multiple programs in parallel, balancing speed with scientific rigor.
• Strong external orientation, with experience overseeing and influencing CRO partners.
• Leadership capability with a commitment to mentoring and developing scientific talent.
• Comfort operating in a build environment, where infrastructure, process, and strategy evolve in real time.

Benefits

The Company prioritizes the holistic well-being of its employees by offering a comprehensive range of health and wellness benefits. From medical and dental coverage to mental health resources and discounts on healthy living programs, it is committed to supporting the health and well-being of its team members and their families.