TEMP - Toxicology Operations Specialist

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 patients with 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:

Perform day-to-day Toxicology and Safety Pharmacology study contracts-related activities. Work with Contract Research Organizations (CROs) to place studies to support the discovery and development of the Company’s development compounds. Coordinate study archiving activities at various CROs. Coordinate domestic and international Test Article (TA) shipments. Review and approve invoices for study and archiving activities.

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Your Contributions (include, but are not limited to):

• Perform day-to-day Toxicology and Safety Pharmacology study contracts-related activities

• Place Toxicology and Safety Pharmacology studies at CROs

• Assist with the management of Toxicology and Safety Pharmacology CROs

• Coordinate domestic and international TA shipments with Toxicology Program Leads, CMC, and the shipping department

• Review and approve invoices from CROs and other vendors as applicable

• Coordinate archival storage activities with various CROs

• Demonstrate proficiency with Neurocine Agiloft Portal (Contracts) and Coupa (Invoices) systems

• Perform periodic review of study tracking database (Smartsheet) for several CROs for accuracy and completeness

• Understand and keep up-to-date with current regulatory guidelines

• Other duties as assigned

Requirements:

• BS degree, 2 years of experience, and knowledge of processes in biotech, pharmaceutical industry and/or CRO, experience in Toxicology is plus

• Previous experience in placing and managing nonclinical studies at CROs

• Ability to work cross-functionally to ensure activities associated with Toxicology and Safety Pharmacology studies are successfully executed

• Proactive to identify and resolve operational problems efficiently

• Strong organization, computer, and communication skills

• Timeline oriented

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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.