Scientific Director, Toxicology

Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit  neurocrine.com , and follow the company on  LinkedIn ,  X , Facebook and YouTube . ( *in collaboration with AbbVie ) About the Role: As a Scientific Leader, serve as the lead for Nonclinical Safety of multiple drug candidates of NBI's pipeline. Represent Nonclinical development as a Toxicology Program Lead (TPL) on discovery and development teams and regularly interfaces with internal and external colleagues to ensure timely and accurate dissemination of Safety Pharmacology and Toxicology findings. Act as the principal evaluator for Due Diligence programs and provide strategic directions for path forward. Review regulatory submission documents of development programs (INDs, CTAs, NDA/MAA, Type C or Type D briefing books, Investigator Brochures, etc.). Lead activities for educational courses, including Best Practices for IND/NDA/BLA submission. As a TPL, develop overall Safety Pharmacology and Toxicology development strategies for successful development of drug candidates. Oversee the execution of Safety Pharmacology and Toxicology studies, advise and direct the study designs, analyze and interpret the data, and review reports for discovery and development programs. Support Sr. Leadership with streamlining Toxicology group performance, regulatory strategic directions for program development, and resource management. Demonstrate excellent communication and leadership skills, with the ability to translate complex scientific findings into actionable insights for cross-functional teams. _ Your Contributions (include, but are not limited to): Serve as the TPL for Nonclinical Safety, shaping the regulatory strategy and execution of nonclinical safety assessments for NBI's pipeline Act as the principal evaluator for Due Diligence programs and provide strategic directions for path forward Review regulatory submission documents of development programs (INDs, CTAs, NDA/MAA, Type C or Type D briefing books, Investigator Brochures, etc.). Lead activities for educational courses, including Best Practices for IND/NDA/BLA submission As a TPL, provide comprehensive support for nonclinical studies, including but not limited to guiding study designs and execution, interpretation of all Safety Pharmacology and Toxicology data/findings, and review the study reports for regulatory submissions Manage and provide scientific leadership to the internal staff and work closely with Discovery, Preclinical and Clinical Pharmacology (PCCP), Clinical Development, and Regulatory to integrate nonclinical safety findings into overall program strategy and goals Represent Preclinical Development on discovery and development-stage program teams Support Sr. Leadership with streamlining Toxicology group performance, regulatory strategic directions for program development, and resource management Maintain current knowledge of regulatory guidance, industry standards and recommendations Oversee and drive the preparation of SOPs as needed