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 to guide functional activities and ensure adherence to all Toxicology SOPs
• Participates in selecting, developing and evaluating personnel to ensure efficient operation within the toxicology group
• Other tasks as assigned

Requirements:

• DVM and/or PhD with specialty training and experience in toxicology and 10+ years of industry experience in toxicology within biotech or pharmaceutical settings
• Diplomate of the American Board of Toxicology (DABT) is preferred but not required
• Expert knowledge in nonclinical safety assessment in drug development of various modalities including but not limited to small molecules, biologics, peptides, and conjugates
• Strong experience of designing, overseeing, and interpreting GLP and non-GLP toxicology studies
• Demonstrate ability to lead and manage internal team members, consultants, and CRO partnerships
• Deep understanding of regulatory requirements for nonclinical safety assessments, including experience with FDA, EMA, and other global health authorities
• Experience in responding to regulatory questions including discussion documents for various Health Authorities in support of discovery and development programs
• Expertise with the design and management of safety pharmacology and toxicology studies (GLP and non-GLP) supporting nonclinical and clinical development programs
• Excellent communication and leadership skills, with the ability to translate complex scientific findings into actionable insights for cross-functional teams
• Proven ability to thrive in a fast-paced, biotech environment

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The annual base salary we reasonably expect to pay is $194,600.00-$265,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 35% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.