Associate Director of Toxicology

Key Responsibilities

• Serve as the internal expert on mapping NAM findings to traditional in vivo results.
• Identify exactly where NAM data can fill gaps in animal data or explain off-target toxicities.
• Support the drafting of toxicology sections for IND-enabling programs, ensuring that human-relevant data is integrated effectively to support clinical entry strategy.
• Lead the design and interpretation of dose-range finding (DRF) and mechanistic toxicology studies that combine standard endpoints with high-fidelity NAM readouts.
• Manage and mentor a team of bench scientists, ensuring R&D and service-based projects are executed with high scientific rigor and technical accuracy.
• Direct complex in vitro assays, including high-content imaging, multiplexed biomarkers, and cell-cycle arrest endpoints.
• Drive the service pipeline forward by identifying new assays or endpoints that align with current client needs and FDA Modernization Act 2.0 trends.
• Act as a technical voice on client calls. Present complex datasets, defend scientific methodologies, and provide expert toxicological context to pharmaceutical partners.
• Partner with the commercial team to provide technical support, helping clients understand how our platform solves their specific safety hurdles (e.g., GI toxicity, liver liability).
• Oversee the creation of high-quality reports, figures, and slide decks that clearly articulate the value of NAM-based insights.

Required Qualifications

• PhD in Toxicology, Pharmacology, or a related field (e.g., Pathology).
• 3-7 years of experience in a CRO, Biotech, or Pharma environment.
• Direct experience with IND-enabling study design and a working knowledge of GLP/GCP requirements.
• Familiar with 3D models, organoids, or microphysiological systems (MPS).
• A track record of successfully managing scientists or project teams in a fast-paced laboratory setting.
• Excellent communication skills, written and verbal.

Preferred Qualifications

• Board Certification (DABT) is a significant plus.
• Experience in specific modalities (e.g., small molecules, ADCs, Monoclonal Antibodies, or Cell & Gene Therapy).
• Experience with Digital Pathology or AI-driven toxicity prediction tools.
• Knowledge of the FDA Modernization Act 2.0 and its practical application in current regulatory submissions.