Neurocrine Biosciences
Principal Scientist, Toxicology
Neurocrine Biosciences, San Diego, California, United States, 92189
Who We Are:
At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs.
What We Do: Neurocrine Biosciences is a leading neuroscience‑focused biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life‑changing treatments for patients with under‑addressed neurological, neuroendocrine and neuropsychiatric disorders. The company’s diverse portfolio includes FDA‑approved treatments for tardive dyskinesia, chorea associated with Huntington’s disease, classic congenital adrenal hyperplasia, 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 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 and Facebook. (in collaboration with AbbVie)
About the Role: Key role in the discovery and development of Neurocrine’s development compounds. Working with Neurocrine colleagues, participates in all stages of Toxicology/Safety Pharmacology assessment, from study planning through to regulatory submission. Will have expertise in either or both study management/oversight or interpretation of study results. Provides strategic and operations direction ensuring all studies are conducted in line with appropriate guidelines and regulatory testing standards and individual program objectives. May represent Toxicology on Development teams and regularly interfaces with colleagues to ensure timely study conduct and/or rapid and accurate dissemination of Toxicology/Safety pharmacology findings.
Your Contributions (include, but are not limited to):
Develops and implements plans for preclinical testing of new and current drug candidates
Selects and manages Toxicology and Safety Pharmacology CROs
Oversees and leads protocol preparation for Toxicology and Safety Pharmacology studies. Manages the conduct and reporting of individual studies, including study placement, contract development/budgeting, coordination of pre‑study activities, and approving study protocols and reports
Performs thorough analyses/interpretations of Toxicology/Safety Pharmacology data and participates in go/no‑go decision making
Prepares SOPs as needed to guide the Toxicology and Safety Pharmacology programs
Authors and/or reviews Toxicology and Safety Pharmacology sections of all regulatory documents, including IND, CTA, IB, annual report, and NDA/MAA submissions
Keeps up‑to‑date with current regulatory guidance
Collects, analyzes, interprets complex data, communicates results, and writes reports in a timely manner
Works collaboratively with other scientists, technicians and colleagues as part of multidisciplinary project teams
Performs quality control checks on non‑clinical pharmacology and toxicology documents for regulatory submission
Assists in the preparation of documents and annual investigational new drug and new drug application reports
May provide support to build and maintain technical databases, archives and department procedures manuals
May lead lower level scientists and/or project teams
Other duties as assigned
Requirements:
BS/BA in Toxicology, Pharmacology, Biology or related discipline required and 12+ years of CRO and/or pharmaceutical industry experience. Experience in small molecules, peptides/peptide conjugates, and/or biologics including monoclonal and bispecific antibodies. Technical leadership experience in managing preclinical Contract Research Organizations. Experience with preparation of INDs, CTDs, NDAs, and MAAs OR
MS/MA degree Toxicology or related field AND 10+ years of similar experience as note above OR
PhD in Toxicology or related field preferred AND 4+ years of relevant experience; may include postdoc experience OR
DABT certification is desirable AND
Assimilates data and research findings outside of Neurocrine for application to new scientific projects
Maintains broad knowledge of scientific principles and theories and possesses intellectual mastery of one or more scientific areas
May develop an understanding of other areas and related dependencies
Advanced knowledge and demonstrated ability working with / recommending a variety of laboratory equipment/tools
Knowledge of preparation of INDs, CTDs, NDAs, and MAAs
Ability to work as part of and lead multiple teams
Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams
Excellent computer skills
Sees broader picture, impact on multiple programs, teams and/or departments
Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
Excellent project management skills
Proactive, innovative, with good problem‑solving skills
Excellent written, presentation, and verbal communication skills
LI‑DM1
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 $166,600.00–$185,900.00. 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 30% 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.
#J-18808-Ljbffr
What We Do: Neurocrine Biosciences is a leading neuroscience‑focused biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life‑changing treatments for patients with under‑addressed neurological, neuroendocrine and neuropsychiatric disorders. The company’s diverse portfolio includes FDA‑approved treatments for tardive dyskinesia, chorea associated with Huntington’s disease, classic congenital adrenal hyperplasia, 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 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 and Facebook. (in collaboration with AbbVie)
About the Role: Key role in the discovery and development of Neurocrine’s development compounds. Working with Neurocrine colleagues, participates in all stages of Toxicology/Safety Pharmacology assessment, from study planning through to regulatory submission. Will have expertise in either or both study management/oversight or interpretation of study results. Provides strategic and operations direction ensuring all studies are conducted in line with appropriate guidelines and regulatory testing standards and individual program objectives. May represent Toxicology on Development teams and regularly interfaces with colleagues to ensure timely study conduct and/or rapid and accurate dissemination of Toxicology/Safety pharmacology findings.
Your Contributions (include, but are not limited to):
Develops and implements plans for preclinical testing of new and current drug candidates
Selects and manages Toxicology and Safety Pharmacology CROs
Oversees and leads protocol preparation for Toxicology and Safety Pharmacology studies. Manages the conduct and reporting of individual studies, including study placement, contract development/budgeting, coordination of pre‑study activities, and approving study protocols and reports
Performs thorough analyses/interpretations of Toxicology/Safety Pharmacology data and participates in go/no‑go decision making
Prepares SOPs as needed to guide the Toxicology and Safety Pharmacology programs
Authors and/or reviews Toxicology and Safety Pharmacology sections of all regulatory documents, including IND, CTA, IB, annual report, and NDA/MAA submissions
Keeps up‑to‑date with current regulatory guidance
Collects, analyzes, interprets complex data, communicates results, and writes reports in a timely manner
Works collaboratively with other scientists, technicians and colleagues as part of multidisciplinary project teams
Performs quality control checks on non‑clinical pharmacology and toxicology documents for regulatory submission
Assists in the preparation of documents and annual investigational new drug and new drug application reports
May provide support to build and maintain technical databases, archives and department procedures manuals
May lead lower level scientists and/or project teams
Other duties as assigned
Requirements:
BS/BA in Toxicology, Pharmacology, Biology or related discipline required and 12+ years of CRO and/or pharmaceutical industry experience. Experience in small molecules, peptides/peptide conjugates, and/or biologics including monoclonal and bispecific antibodies. Technical leadership experience in managing preclinical Contract Research Organizations. Experience with preparation of INDs, CTDs, NDAs, and MAAs OR
MS/MA degree Toxicology or related field AND 10+ years of similar experience as note above OR
PhD in Toxicology or related field preferred AND 4+ years of relevant experience; may include postdoc experience OR
DABT certification is desirable AND
Assimilates data and research findings outside of Neurocrine for application to new scientific projects
Maintains broad knowledge of scientific principles and theories and possesses intellectual mastery of one or more scientific areas
May develop an understanding of other areas and related dependencies
Advanced knowledge and demonstrated ability working with / recommending a variety of laboratory equipment/tools
Knowledge of preparation of INDs, CTDs, NDAs, and MAAs
Ability to work as part of and lead multiple teams
Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams
Excellent computer skills
Sees broader picture, impact on multiple programs, teams and/or departments
Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
Excellent project management skills
Proactive, innovative, with good problem‑solving skills
Excellent written, presentation, and verbal communication skills
LI‑DM1
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 $166,600.00–$185,900.00. 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 30% 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.
#J-18808-Ljbffr