Senior Director, Toxicology

Lindonlight is dedicated to the discovery and development of transformative therapies for pediatric brain tumors. The organization operates as an integrated ecosystem comprised of the Lindonlight Foundation, Lindonlight Collective, and Lindonlight Bio. Within this ecosystem, Lindonlight Bio is focused on developing promising therapeutics for pediatric glioma.

Lindonlight is seeking a Senior Director, Toxicology to serve as the primary toxicology expert across the organization’s pipeline and lead the design, execution, and interpretation of nonclinical safety programs from early discovery through IND filing and clinical development.

This individual will develop scientifically sound, globally acceptable toxicology strategies for a research and development portfolio spanning multiple therapeutic modalities, including small molecules, biologics, antibody-drug conjugates, oligonucleotides, and gene therapies. The Senior Director will work closely with Chemistry, Biology, DMPK, CMC, Regulatory, and Clinical teams to integrate toxicology strategy into development plans, identify and mitigate potential safety liabilities, and support regulatory submissions and interactions.

The successful candidate will also oversee external toxicology and safety pharmacology studies, provide strategic guidance to project teams and senior leadership, and support resource planning, budgeting, and the continued development of the toxicology function.

• Develop, implement, and direct scientifically sound and regulatory authority-acceptable toxicology strategies supporting safety assessments from early discovery through clinical development and market authorization.
• Lead the planning and execution of safety pharmacology and toxicology studies and data packages across the portfolio.
• Oversee assignments and priorities within the toxicology function to ensure timely completion of critical activities.
• Evaluate, interpret, and summarize safety pharmacology and toxicology findings, and advise project teams and senior leadership on their potential impact on program, clinical, and regulatory strategy.
• Integrate nonclinical safety data across disciplines to support candidate selection, dose selection, risk assessment, clinical translation, and go/no-go recommendations.
• Represent Toxicology in internal program team meetings, governance reviews, and external scientific or regulatory discussions.
• Provide strategic oversight for data summaries, presentations, and recommendations to peers, colleagues, and senior leadership.
• Maintain current knowledge of evolving regulatory guidance, scientific literature, industry standards, and best practices in nonclinical safety and toxicology.

• Design, oversee, and interpret in vitro and in vivo toxicology studies across a range of therapeutic modalities. (ADCs, biologics, small molecules, and other modalities as the portfolio evolves)
• Oversee safety pharmacology and toxicology studies, including protocol design, study execution, data interpretation, and review of final reports.
• Prioritize CNS penetration and pediatric-specific safety considerations across study design and interpretation.
• Ensure toxicology studies and programs are conducted in accordance with applicable regulatory guidance, test standards, and Good Laboratory Practice requirements.
• Lead or contribute to the preparation of toxicology and safety pharmacology sections for INDs, CTAs, BLAs, NDAs, MAAs, NMPA submissions, briefing books, Investigator’s Brochures, and other regulatory documents.
• Serve as a key contributor to regulatory authority interactions and overall development strategy by interpreting safety data in the context of global regulatory…