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, but few options.

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. 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, 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, visitneurocrine.com, and follow the company on LinkedIn, X (Formerly Twitter) and Facebook. (*in collaboration with AbbVie)

About the Role:

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• Develops and implements study protocols consistent with the Development Team direction

• Assists in the identification and selection of clinical investigators for clinical trials

• Maintains appropriate communication and professional relationship with NBI Clinical Investigators

• Conducts assessment and disposition of adverse events (in conjunction with Medical Director if non-physician) and evaluates safety of clinical compounds prior to and during ongoing clinical studies

• Leads effort within clinical development program teams on selection of established and development of novel outcome measures in the context of clinical trials in early and late stages of clinical development

• Leads data monitoring activities of ongoing studies to maintain quality of database, obtain clarification for questionable or missing information and look for data trends that may warrant action by Development Team

• Analyzes, interprets, and presents results of clinical studies to internal and external audiences as directed by Sr. Management

• Participates on multidisciplinary project teams

• Collaborates with external opinion leaders, internal clinicians, translational sciences and clinical operations to ensure appropriate study designs and operational choices for successful implementation of data analyses and accomplishment of intended study outcomes

• Provides or assists in the scientific writing and review of clinical study reports and related documents

• Provides periodic status updates and effectively communicate with Senior Management Team

• Remains up-to-date with current information on pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities

• Maintains knowledge of ICH-GCP, external regulations and procedures - required for regulatory filing

• Other duties as assigned

• MS degree in Life Sciences or related field and 10+ years of related experience in industry with expertise in the areas of drug development, operations and strategic plannings. Specialty training appropriate to therapeutic area in addition to experience in clinical drug development (Phase 1-4) in a pharmaceutical/biotechnology company. Prior experience working with CRO is a plus. OR

• PharmD or PhD degree preferred and 7+ years of similar experience noted above. OR

• MD a plus and 5+ years of similar experience noted above

• Extensive knowledge of clinical drug development is mandatory and should include prior experience with clinical development planning, regulatory requirements and documents, study design, biostatistics, monitoring, data handling, data analysis, report writing, and scientific presentation of data

• Must be able to effectively operate in a multi-level matrix corporate environment, requiring interaction with, and/or direction of, internal and external personnel, including physicians, scientists, monitors, administrative, regulatory, commercial, and consultant personnel

• Expertise in the areas of drug development, operations and strategic planning

• Expertise in submissions from investigational new drug through new drug application filings and managing a product from pre-clinical through all clinical phases and product launch

• Recognized as an internal thought leader with extensive technical and business expertise within a strategic organization

• Applies in-depth knowledge of own function, business / commercial / scientific expertise to solve critical issues successfully and innovatively

• Evaluates key business / scientific challenges and completes complex, ambiguous initiatives having cross-functional impact

• Strong interpersonal and communication skills as well as strong organizational and team leadership skills are required

• Ability to apply advanced analytical thought and judgment

• Strong leadership, coaching, employee development skills

• Ability to influence others with or without authority at all levels of the organization

• Proactive, innovative, with good problem-solving skills

• Ability to work in a cross functional team and matrix environment

• Excellent written, presentation, and verbal communication skills

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Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.

We are committed to building a diverse, equitable, and inclusive workplace, 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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