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San Diego, California, United States
Onsite
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)
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Support translational biomarker and target-engagement activities for First In Human (FIH) and early-phase studies, and related preclinical work, in alignment with Translational Medicine strategies
Apply quantitative LC-MS approaches to proteins, peptides, endogenous small molecules, and other biomarkers as appropriate to program needs.
Coordinate day-to-day activities with CROs and external vendors, including assay laboratories, and support assay feasibility, fit-for-purpose method development and qualification, troubleshooting, and sample analysis
Track vendor contracts, scopes of work, budgets, and timelines in collaboration with internal stakeholders
Utilize Smartsheet, Excel and other project management tools to track operational deliverables, risks, and dependencies
Support integration of biomarker and assay plans into preclinical and clinical protocols and study execution plans
Monitor vendor and analytical method performance, critically evaluating data quality, assay sensitivity, selectivity, precision, reproducibility, and issues impacting timelines or interpretation
Collaborate cross-functionally with Research, Translational Medicine, Clinical Development, Bioanalytics, DMPK, Pharmacology, Data Science, Clinical Operations, Outsourcing, Regulatory, Quality Assurance, Data Management, and other stakeholders to support strategy and execution
Drive planning, implementation, and execution of clinical specimen collection, testing, and data delivery activities in close collaboration with cross-functional teams
Maintain accurate documentation to support GxP compliance, ensuring activities are conducted in accordance with GxP requirements, internal SOPs, and applicable regulatory guidance
Work across Research and Translational Medicine to connect emerging biological findings with quantitative measurements that can be evaluated in preclinical and clinical studies
Provide regular project updates and communicate scientific findings, analytical limitations, and recommendations to multidisciplinary teams
Other duties as assigned
BS/BAMS in Biology, Chemistry, or related scientific field AND 2+ years of relevant industry experience OR
MSMS in Biology, Chemistry, or related scientific field AND some relevant industry experience OR
PhD in Biology, Chemistry, or related scientific field AND some relevant industry experience
Operational rigor and attention to detail
Consistent ability to meet multiple deadlines, with a high degree of accuracy and efficiency
Strong execution mindset with ability to anticipate and manage risks
Collaborative, team-oriented approach
Ability to translate scientific and operational requirements into actionable plans
Ability to manage multiple priorities and collaborate effectively across functions
Strong written and verbal communication skills
Experience supporting first-in-human or early-phase clinical studies
Experience working with CROs and external laboratories supporting clinical studies
Strong organizational and project management skills; experience with Smartsheet preferred
Familiarity with clinical biomarker workflows and early clinical development
Working knowledge of GxP requirements and biomarker or bioanalytical operations
Experience working with CROs to support clinical assay development and sample testing
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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 $89,800.00-$123,000.00. 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 20% 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.