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)
As a Sr. Leader, leads and executes the scientifically sound and regulatory authority-acceptable toxicology strategies that support safety assessments for a Research and Development portfolio spanning early drug discovery through clinical development and market authorization. Recommends longer term strategies to ensure effective achievement of strategic and operational objectives. Oversees the safety pharmacology and toxicology studies including protocol design, advises and directs the execution, data interpretation, and review of reports for new therapeutic entities of various modalities (small molecules, large molecules, peptide conjugates, oligonucleotides, and gene therapies). Ensures that toxicology studies and programs are conducted in accordance with the appropriate guidelines and regulatory test standards (FDA, ICH, WHO, GLP, and ISO). Represents Toxicology and work closely with Research and Development functions to integrate toxicology strategies into the research/development plan, provide scientific insight into the safety profile, and de-risk potential safety liabilities. Supports Sr. Leadership with in-life resource planning, maintaining current testing procedures, program development, performance monitoring, budget planning and resource management.
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Develops, implements and directs the 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
Supports planning and execution of Safety Pharmacology and Toxicology studies/data for all programs
Oversees and directs assignments within the regulatory Toxicology function to ensure timely completion of priority activities
Evaluates, interprets and summarizes safety pharmacology and toxicology results and proactively provides strategic direction to project teams and senior management on the potential impact of results on Program and Clinical/Regulatory strategy
Advises and directs the preparation of Safety Pharmacology and Toxicology sections of regulatory documents (INDs, CTAs, BLAs/NDAs/MAAs, briefing books, Investigator’s Brochures, etc.)
Represents 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
Provides strategic oversight and direction for the preparation of data summaries and contributes to the presentation of results to peers, colleagues and Neurocrine Management
Oversees and drives the preparation of SOPs as needed to guide functional activities and ensures adherence to SOPs
Oversees the adherence of regulatory toxicologists to all Toxicology SOPs
Maintains current knowledge of regulatory guidance, industry standards and recommendations
Participates in the selecting, developing and evaluating personnel to ensure the efficient operation within the toxicology group
Other tasks as assigned
PhD in Toxicology, Pathology or closely related discipline and 10+ years of pharmaceutical/biotech experience, including managing clinical Contract Research Organizations
D.V.M. and 8+ years of similar experience noted above
Expert knowledge in development of various modalities, especially Biotherapeutics (bispecific or trispecific antibodies, BBB shuttles, peptide conjugates), oligonucleotides, and gene therapies desired
Demonstrated experience in the preparation of INDs, CTAs, BLAs/NDAs/MAAs, briefing books, Investigator’s Brochures
Expert in regulatory strategies for various modalities in US, Canada, and Europe
Demonstrate 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 (CRO's)
Exhibits ability to become company-wide advisor and emerging industry expert.
Possesses expert knowledge of own function and broad knowledge of multiple functions and impact on business
Proven leadership skills and ability, including influencing across many levels of the organization
Maintains broad knowledge of scientific principles and theories and possesses intellectual mastery of multiple scientific areas
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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.
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The annual base salary we reasonably expect to pay is $226,600.00-$309,000.00. 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.
