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. Position Summary 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. Responsibilities and Opportunities 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. Study Design & Regulatory Support 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 expectations. Develop and maintain SOPs and other functional procedures, and ensure adherence across the toxicology function. CRO & External Partner Management Oversee and manage multiple contract research organizations and external partners supporting outsourced toxicology and safety pharmacology studies. Establish clear study scopes, protocols, timelines, deliverables, and success criteria to ensure scientifically rigorous, high-quality, and on-time execution. Monitor study performance, budgets, data quality, and compliance, and proactively address risks or deviations. Build productive relationships with external scientific experts, academic collaborators, and industry partners to extend internal capabilities. Cross-Functional & Executive Engagement Partner closely with Chemistry, Biology, DMPK, Bioanalytics, Pharmacology, Translational, CMC, Regulatory, and Clinical teams to support cohesive and efficient program advancement. Provide scientific insight into program safety profiles and recommend strategies to identify, characterize, and mitigate potential safety liabilities. Support senior leadership with resource planning, program development, performance monitoring, budget planning, and resource management. Serve as a senior scientific representative in partnering, investor, board, and other external discussions, as needed. Build, mentor, and lead a high-performing toxicology function appropriate for a growing biotechnology organization. Participate in the selection, development, and evaluation of personnel to support efficient operation of the toxicology group. Foster a culture of scientific rigor, accountability, collaboration, and sound decision-making. Establish best practices, workflows, and decision frameworks that enable effective portfolio execution. Qualifications Required: PhD in Toxicology, Pharmacology, Pharmaceutical Sciences, Cell Biology, or a closely related field. Diplomate of the American Board of Toxicology (DABT) certification. 10+ years of experience in a pharmaceutical or biotechnology industry setting, with demonstrated expertise across early- to late-stage drug development. Deep understanding of regulatory expectations for preclinical development, including IND submission requirements and familiarity with one or more global regulatory frameworks or agency standards, such as FDA, EMA, ICH, and NMPA/CDE. Strong working knowledge of GLP regulations and their application to nonclinical development programs. Proven experience managing multiple CROs and outsourced toxicology programs. Track record of successfully contributing to IND filings and regulatory interactions. Experience authoring or contributing to regulatory submissions for IND and beyond. Experience with diverse therapeutic modalities, such as small molecules, biologics, ADCs, oligonucleotides, or gene therapies. Excellent written and verbal communication skills, with the ability to distill complex toxicology data for cross-functional and executive audiences. Preferred: Track record of advancing biologics through late-stage development, BLA submission, and/or regulatory approval. Experience with ADCs, ADC payloads, and/or targeted delivery platforms. Familiarity with regulatory expectations for biologics CMC and comparability. Experience building and scaling teams in a startup or high-growth biotechnology environment. Leadership Attributes Strategic thinker with strong scientific judgment and an execution-focused mindset. Comfortable operating in ambiguous, resource-constrained environments. Collaborative, decisive, and hands‑on leader. Credible scientific voice with internal and external stakeholders. Additional Information Job Type: Full-time; Hybrid; In-person two days per week Schedule: Monday to Friday; Weekends as needed Work Hours: Requires flexibility to accommodate recurring evening meetings with international collaborators across time zones, including Europe and Asia, approximately 2–3 times per week. Travel: Approximately 15–20% | Includes one week of travel per month to Houston or Boston and occasional travel for scientific meetings or partnership engagements. Compensation: Expected base salary range: $190,000 - $260,000 Final salary will be based on candidate’s experience, qualifications, and overall fit for the position. 401(k) with company match Health, dental, and vision insurance Paid time off Lindonlight is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or any other legally protected status. #J-18808-Ljbffr Lindonlight