Scientist, Translational Medicine
Neurocrine Biosciences
Summary
Focuses on scientific and operational delivery of translational biomarker and target-engagement activities across assigned Therapeutic Area (TA) programs, with emphasis on biological mass spectrometry and quantitative bioanalysis. Will support execution through selection of fit-for-purpose analytical approaches, vendor coordination, method development and qualification, integration into preclinical and clinical studies, and sample testing at CROs, working closely with Research, Translational Medicine, Clinical Development, Clinical Operations, and external partners.
Job description
About the Role
Focuses on scientific and operational delivery of translational biomarker and target-engagement activities across assigned Therapeutic Area (TA) programs, with emphasis on biological mass spectrometry and quantitative bioanalysis. Will support execution through selection of fit-for-purpose analytical approaches, vendor coordination, method development and qualification, integration into preclinical and clinical studies, and sample testing at CROs, working closely with Research, Translational Medicine, Clinical Development, Clinical Operations, and external partners.
Your Contributions (include, but are not limited to):
- 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
Requirements
- BS/BA/MS in Biology, Chemistry, or related scientific field AND 2+ years of relevant industry experience OR MS/MS 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
Benefits
- 401(k) Matching
- Paid Vacation
- Paid Holidays
- Paid Personal Days
- Paid Caregiver Leave
- Paid Parental Leave
- Paid Medical Leave
- Medical Insurance
- Prescription Drug Coverage
- Dental Insurance
- Vision Coverage
- Annual Bonus
- Equity Long-Term Incentive
Company overview
Neurocrine Biosciences is a leading neuroscience-focused biopharmaceutical company founded in 1992 and headquartered in San Diego, California. The company specializes in discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. Neurocrine's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis, and uterine fibroids. Their flagship product, INGREZZA (valbenazine), was the first FDA-approved treatment for adults with tardive dyskinesia. The company maintains a robust pipeline with multiple compounds in mid- to late-phase clinical development across core therapeutic areas, including Parkinson's disease, Tourette syndrome, and major depressive disorder. Neurocrine operates with a purpose to relieve suffering for people with great needs, applying unique insights into neuroscience and the interconnections between brain and body systems to treat complex conditions. The company is publicly traded on NASDAQ under the symbol NBIX and has established strategic collaborations with major pharmaceutical partners including AbbVie.