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Job description
Who We Are:
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 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
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. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.
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:
retirement savings plan (with company match)
paid vacation
holiday and personal days
paid caregiver/parental and medical leave
health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans
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Worksite address
san diego, CA, 92189, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.