Director/Associate Director, Toxicology

Who We AreCalico (Calico Life Sciences LLC) is an Alphabet-founded research and development company whose mission is to harness advanced technologies and model systems to increase our understanding of the biology that controls human aging. Calico will use that knowledge to devise interventions that enable people to lead longer and healthier lives. Calico’s highly innovative technology labs, its commitment to curiosity-driven discovery science and, with academic and industry partners, its vibrant drug-development pipeline, together create an inspiring and exciting place to catalyze and enable medical breakthroughs.Position DescriptionCalico is seeking an accomplished and motivated individual to step into the role of Nonclinical Safety Leader within our Toxicology and Pathology team. This leader will collaborate with innovative and diverse scientists and play a pivotal role in advancing Calico’s preclinical pipeline and development portfolio. The ideal candidate will leverage deep and proven expertise in toxicology to provide leadership for discovery and development projects, with flexibility to specialize or work across stages of development, therapy areas, and modalities.ResponsibilitiesAct as a Nonclinical Safety representative and Subject matter expert representing toxicology on project teams to support on early- and late-stage project development teamsProactive risk assessment of potential target pharmacology and chemotype-related toxicity issues, preparing safety strategies, and designing and implementing studies to drive toxicology plansProvides scientifically and strategically sound nonclinical development plans to management and development teamsOversee the proper design and timely reporting of toxicity studies (GLP/nonGLP), including single- and repeat-dose toxicity, investigative toxicity, and other toxicity studies as requiredAnalyze and interpret toxicological data, ensuring accuracy and compliance with regulatory standards, and communicate toxicology findings to management and development teamsBe accountable for authoring and review of global regulatory nonclinical documents such as CTD sections for INDs and NDAs, IBs, PIPs and health authority responses (briefing books) to support clinical trials and drug registration globallyContribute to global regulatory submissions (e.g., IBs, Briefing Books, INDs, NDA/BLAs) and interact with regulatory authorities worldwide on issues of nonclinical safety evaluationRepresent Calico in external scientific and regulatory collaborations, committees and consortiaParticipate in nonclinical safety risk assessments for due diligence of potential external opportunitiesEnsure compliance with Good Laboratory Practice, Standard Operating Procedures, and study protocols in conducting nonclinical studies, when applicablePosition RequirementsPhD in Toxicology or related scientific discipline with 8+ years of regulatory toxicology/development experienceBoard certification (e.g. Diplomate of the American Board of Toxicology (DABT))Demonstrated and proven track record of successfully delivering small and large molecule candidates that have achieved preclinical candidate nomination and progressed into clinical development as the project toxicologistExperience in representing toxicology/nonclinical safety on multi-disciplinary project teamsExperience in conducting or overseeing nonclinical studies with small and large moleculesExtensive knowledge of GLP principles and FDA/ICH guidelinesExperience in conducting due diligence of nonclinical safety dataSelf-motivated, enthusiastic, and highly adaptable with the ability to quickly identify project challenges and pivot strategies in a fast-paced environmentExceptional oral communication and writing skills, with record-keeping and data organization skillsMust be willing to work onsite at least 4 days a weekNice To HaveExperience in developing and applying advanced in vitro models (co-culture systems, iPS-derived cells, spheroids, organoids, organ-on-a-chip) or new approach methodologies (NAMs) to address mechanistic/investigative toxicology questionsThe estimated base salary range for this role is $235,000 - $315,000. Actual pay will be based on a number of factors including experience and qualifications. This position is also eligible for two annual cash bonuses