Senior Director, Toxicology & DMPK

Role Summary

The Senior Director, Toxicology & DMPK provides nonclinical safety and DMPK expertise across the development of oral small molecules and biologics. Serves as the primary expert in predicting human safety and exposure, integrating toxicology, ADME, and PK/PD insights to support candidate selection and clinical development. Reports to the Chief Scientific Officer and collaborates with discovery biology, clinical pharmacology, regulatory affairs, and program leadership.

Responsibilities

• Provide scientific and strategic leadership for all toxicology and DMPK activities across small molecules and biologics
• Design and oversee preclinical toxicology and safety pharmacology plans, including GLP studies, mechanism-based investigations, and regulatory submission packages
• Select and oversee CROs to conduct GLP safety and toxicology studies
• Evaluate and strategically implement established in vitro toxicology assays and in silico tools that support safety assessment in drug discovery
• Collaborate with in-house vivarium team to design and coordinate in-house tolerability studies in rodents
• Direct the DMPK function encompassing in vitro ADME profiling, in vivo PK, and translational modeling to enable confident human dose projections
• Serve as the nonclinical safety lead on project teams and communicate risk assessments to senior management
• Partner with discovery and development teams to guide candidate optimization with respect to metabolic stability, clearance, and exposure margins
• Develop and maintain relationships with CROs, ensuring quality, timelines, and budget compliance
• Interpret results, and author, review, and approve nonclinical sections for INDs, IBs, and regulatory responses
• Lead and mentor DMPK scientists, cultivating innovation, scientific rigor, and operational excellence
• Keep abreast of regulatory and scientific developments relevant to safety assessment, translational toxicology, and model-informed drug development
• Represents nonclinical safety in interactions with regulatory agencies (e.g., FDA, EMA, PMDA)

Qualifications

• Education: Ph.D. in Toxicology or related discipline (e.g., Pharmacology, Pharmaceutical Sciences, ADME sciences); DABT preferred. Exceptional candidates with Pharm.D. or M.S. and extensive (15+ years) experience will be considered
• Experience: 15+ years of experience, including 7+ years leading toxicology and DMPK teams and programs
• Experience leading integrated nonclinical safety and PK strategies for small molecule and biologic programs through IND and clinical phases
• Deep understanding of ADME processes, species translation, IVIVE, allometric scaling, and human dose prediction methods
• Experience managing GLP tox studies and authoring regulatory submissions in the US and internationally
• Knowledge of immunology or inflammation is a plus
• Other qualifications: Experience designing toxicology and safety assessments for advanced stage clinical candidates; strong leadership and teamwork skills; excellent problem-solving, written and oral communication; ability to work in a high-paced, multidisciplinary environment; openness to an open, collaborative culture

Additional Requirements

• On-site preferred for local candidates; hybrid flexibility may be considered for exceptional candidates