Principal Scientist, Translational Medicine

Principal Scientist, Translational Medicine page is loaded## Principal Scientist, Translational Medicineremote type: On-Sitelocations: US CA San Diegotime type: Full timeposted on: Posted 2 Days Agojob requisition id: R6858## 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, and follow the company on,, and. (*\*in collaboration with AbbVie*)## About the Role:As a key contributor to the clinical biomarker strategy, accountable for working effectively with cross-functional teams on the planning, implementation, and execution of clinical biomarker testing, and data delivery activities. Integrate scientific and operational expertise through cross functional partnerships, management of external CROs, strategic project planning and facilitating key biomarker execution components of clinical trials.\_## Your Contributions (include, but are not limited to):* 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## Requirements:* 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#LI-RS1Neurocrine 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.\_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. #J-18808-Ljbffr Neurocrine Biosciences