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.
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)
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Directs the activities of bioanalytical scientists in support of the research and/or development of an organization's products, projects and programs
Monitors and evaluates completion of tasks and projects
Will manage conduct of BA/PK/TK studies internally as well as at external CROs
Lead and manage non-regulated and regulated bioanalysis activities for multiple drug development programs, from preclinical development through First-in-Human (FIH) studies
Build and strengthen bioanalysis infrastructure internally as well as with external CRO partners to support preclinical, GLP Toxicology and FIH studies for multiple modalities including small molecules, peptides, biologics, conjugates, and oligonucleotides
Oversee bioanalytical method development, validation, and sample analysis for preclinical and/or clinical studies
Collaborate with internal Neurocrine teams to generate critical reagent generations for bioanalytical method development
Implement and maintain project tracking systems for bioanalytical methods, sample analysis, and critical reagents
Participate in CRO vendor qualification and audits
Will contribute to the preparation and/or review of regulatory submissions and study reports
Mentor and train team members in bioanalytical procedures and regulatory requirements
Other duties as assigned
BS/BA degree in chemistry/biology or a related discipline and 6+ years of experience in bioanalytical and pharmacokinetic/toxicokinetic project management, CRO management and pharmacokinetic modeling. Small and Large molecule bioanalysis, non-compartmental PK data analysis
Master's degree in chemistry/biology or a related discipline and 4+ years of similar experience noted above
PhD in chemistry/biology or a related discipline and 1+ years of similar experience noted above
Extensive expertise in in vivo animal dosing techniques and microsampling for PK studies
Extensive expertise in bioanalytical method development, validation, and sample analysis across multiple modalities (small molecules, peptides, biologics, conjugates, oligonucleotides)
Demonstrated experience with regulatory requirements (FDA, EMA, ICH guidelines) and GLP regulations, including successful contributions to regulatory submissions
Proven track record in CRO management, vendor relationships, and oversight of outsourced bioanalytical studies
Experience in working with external CRO partners in generation of critical PK/TK and immunogenicity data for preclinical, and/or GLP toxicology and FIH studies
Strong technical background in various bioanalytical techniques including LC-MS/MS, immunoassays, and biomarker analysis
Exceptional project management skills with experience in budget management, resource allocation, and timeline tracking across multiple concurrent programs
Demonstrated leadership ability in directing cross-functional teams, mentoring staff, and driving process improvements
Excellence in technical writing, presentation skills, and cross-functional communication with ability to influence key stakeholders
Proven success in establishing and maintaining bioanalytical infrastructure, including implementation of tracking systems and quality control procedures
Strong strategic thinking and problem-solving abilities with a track record of driving program success and delivering high-quality results in a fast-paced environment
Ability to mentor and direct the day-to-day work of less experienced team members
Excellent computer skills, strong problem-solving, analytical thinking skills
Detail oriented yet can see broader picture of scientific impact on team
Ability to meet multiple deadlines, with a high degree of accuracy and efficiency
Strong written and verbal communication skills
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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 $130,800.00-$179,000.00. 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 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.