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 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)
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Collaborate with biomarker scientists and clinical teams to design biomarker strategies for clinical trials, including selecting appropriate assay platforms, defining assay parameters, and developing protocols
Serve as assay SME in at least one technical area to independently identify and guide CROs with biomarker validation, experimental design, troubleshooting, and method development as required
Maintain a network of specialty biomarker vendors to help select the best CROs for the proposed work and ensure vendors meet quality standards and certification
Work in partnership with scientific/clinical leads, procurement, contracting and compliance teams to negotiate contracts, prepare statements of work, oversee contract execution status and ensure deliverables meet program requirements.
Manage relationships with CROs to ensure biomarker data is collected in an ethical and high-quality manner. Ensure data is reported to meet development timelines while ensuring data quality and assay performance
Work closely with data management to establish data collection, data reconciliation, and transfer specifications with CROs
Contribute to the preparation of clinical documents such as lab report templates, lab manuals, informed consent forms, eCRF, sample/data management plan, early development plans, and site training materials
When relevant, oversee the collection, handling, storage, and shipment of clinical trial samples to external laboratories
Apply and adhere to ICH/GCP, sample storage procedures, sample management best practices, and ethical guidelines
Maintain biomarker related budgets for assay development/validation, in-study sample testing, and long-term sample storage
Other duties as assigned
10+ years of applicable experience/training OR
BS/BA degree in Biology, Chemistry, or related science field AND 6+ years of relevant experience, or OR
Master’s in Biology, Chemistry, or related science field AND 4+ years of related experience, or OR
PharmD or PhD AND 2+ years of related experience
Consistent ability to meet multiple deadlines, with a high degree of accuracy and efficiency
Excellent written, presentation, and verbal communication skills
Proactive, innovative, with exceptional problem-solving and analytical skills
Ability to lead and/or work as part of a team; typically leads and trains junior scientists and/or other team members
Working knowledge of FDA guidance on biomarker method validation and related regulatory aspects
Established scientific background on clinical biomarkers and commonly used methodologies
Deep expertise on at least one biomarker platform (i.e. neuroimaging, electrophysiology, or biofluid biomarkers), with general broad understanding of how other biomarker modalities can be integrated into clinical development strategies
Experience with clinical study operations teams and understanding of clinical drug development strategic planning of clinical research
Extensive experience working with CROs to support clinical assay development and sample testing
Experience with regulatory filings and interactions.
Experience in GLP, GMP and/or GCP regulated environments and studies
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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.Want to know if this job is worth applying to?