Sr. Scientific Director, Toxicology

About the Role Sr. Leader responsible for developing, implementing, and executing scientifically sound and regulatory authority‑acceptable toxicology strategies that support safety assessments for a R&D portfolio spanning early drug discovery through clinical development and market authorization. Responsibilities Develop, implement, and direct toxicology strategies that support safety assessments for a R&D portfolio spanning early drug discovery through clinical development and market authorization. Support planning and execution of safety pharmacology and toxicology studies/data for all programs. Oversee and direct assignments within the regulatory toxicology function to ensure timely completion of priority activities. Evaluate, interpret, and summarize safety pharmacology and toxicology results and proactively provide strategic direction to project teams and senior management on the potential impact of results on program and clinical/regulatory strategy. Advise and direct the preparation of safety pharmacology and toxicology sections of regulatory documents (INDs, CTAs, BLAs/NDAs/MAAs, briefing books, Investigator’s Brochures, etc.). Represent toxicology and work closely with R&D functions to integrate toxicology strategies into the research/development plan, provide scientific insight into the safety profile, and de‑risk potential safety liabilities. Provide strategic oversight and direction for the preparation of data summaries and contribute to the presentation of results to peers, colleagues, and Neurocrine Management. Oversee and drive the preparation of SOPs as needed to guide functional activities and ensure adherence to SOPs. Oversee the adherence of regulatory toxicologists to all toxicology SOPs. Maintain current knowledge of regulatory guidance, industry standards, and recommendations. Participate in the selection, development, and evaluation of personnel to ensure efficient operation within the toxicology group. Other tasks as assigned. Requirements PhD in Toxicology, Pathology, or a closely related discipline and 10+ years of pharmaceutical/biotech experience, including managing clinical contract research organizations. D.V.M. with 8+ years of similar experience. Expert knowledge in development of various modalities, especially biotherapeutics (bispecific or trispecific antibodies, BBB shuttles, peptide conjugates), oligonucleotides, and gene therapies. Demonstrated experience in the preparation of INDs, CTAs, BLAs/NDAs/MAAs, briefing books, Investigator’s Brochures. Expertise in regulatory strategies for various modalities in the US, Canada, and Europe. Demonstrated strategy development and implementation within areas of responsibility. Expert knowledge of global Good Laboratory Practices and health authority requirements for nonclinical safety data that support clinical trials and market authorization of investigational medicinal products. Extensive experience in managing clinical contract research organizations (CROs). Ability to become a company‑wide advisor and emerging industry expert. Expert knowledge of own function and broad knowledge of multiple functions and their impact on business. Proven leadership skills and ability to influence across many levels of the organization. Broad knowledge of scientific principles and theories and intellectual mastery of multiple scientific areas. Compensation & Benefits The annual base salary range is $226,600.00–$309,000.00, with an annual bonus target of 35% of earned base salary and eligibility for a long‑term equity incentive program. Benefits include a retirement savings plan with company match, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and comprehensive health, prescription drug, dental, and vision coverage. Equal Opportunity Statement Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. #J-18808-Ljbffr Neurocrine Biosciences