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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, but few options.
What We Do:Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis* and uterine fibroids*, as well as clinical programs in multiple 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. *in collaboration with AbbVie
About the Role:
As a Sr. Leader, executes the strategic direction of the Toxicology function. Ensures that toxicology studies and programs are conducted in accordance with the appropriate guidelines and regulatory test standards (FDA, WHO, GLP, and ISO). Oversees and evaluates protocol preparation for toxicology studies and reviews reports. Advises and directs the analysis, interpretation and reporting of Safety Pharmacology and Toxicology data for discovery and development programs. Designs and develops overall Safety Pharmacology and Toxicology development strategies for toxicology programs. Recommends longer term strategies to ensure effective achievement of strategic and operational objectives. Represent Preclinical development 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. Supports Sr. Leadership with in-life resource planning, maintaining current testing procedures, program development, performance monitoring, budget planning and resource management._
Your Contributions (include, but are not limited to):Develops, implements and directs toxicology strategies to support assigned discovery and development programs
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
Evaluate, interpret and summarize toxicology results and proactively provides strategic direction to project teams and senior management on the potential impact of toxicology results on Program and Clinical/Regulatory strategy
Advises and directs the preparation of Safety Pharmacology and Toxicology sections of regulatory documents (IND, CTA, NDA, briefing books, Investigator Brochures, etc.)
Represent Preclinical Development on discovery and development-stage program teams
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
Maintain 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. Experience in toxicologic pathology is beneficial OR
D.V.M. and 8+ years of similar experience noted above
Exhibits ability to become company-wide advisor and emerging industry expert
Demonstrated strategy development and implementation within areas of responsibility
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
Expert knowledge of drug development strategies for various modalities including small molecules, biologics, therapeutic peptides, therapeutic areas (including neuroscience and endocrineology) and regulatory regions including US, Canada, Europe and Japan
Expert knowledge of toxicologic pathology is beneficial
Expert knowledge of managing clinical Contract Research Organizations (CRO's)
Demonstrated experience in the of preparation of INDs, CTAs, NDAs, and MAAs
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/AA/Disability/Vets employer.
We are committed to building a diverse, equitable, and inclusive workplace, 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 $217,300.00-$314,725.00. 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.