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.
Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. 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, classic congenital adrenal hyperplasia, 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, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (*in collaboration with AbbVie)
Responsible for developing strategy and plans for Phase 1-3 clinical studies while working with a multidisciplinary team (R&D project teams, clinical project managers, statisticians, data management, regulatory, drug safety). As needed, interfaces with Research and Business Development to assess new product opportunities, develop clinical research strategy and product development plans.
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Directs Phase 1-3 Clinical Trials for the clinical development in accordance with Neurocrine SOPs and GCP guidance
Develops and implement 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
Oversees the clinical trials program in conjunction with the Clinical Operations
Analyzes, interprets, and presents results of clinical studies to internal and external audiences as directed by Sr. Management
Participates on multidisciplinary project teams
Identifies resource requirements, assists in budget planning and personnel forecasting for clinical research programs
Assists in the recruitment, training and development of the clinical teams to ensure efficient operation of the function
Identifies and selects clinical consultants. Collaborates with external opinion leaders. internal clinicians, translational sciences and clinical operations to ensure appropriate study designs are achieved 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
Responsible for developing the infrastructure to support advanced clinical trials
Sets strategy for regulatory processes with responsibility for all submissions and interactions with the FDA and other regulatory authorities
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. Extensive previous managerial experiences also required OR
PharmD or PhD degree preferred AND 7+ years of similar experience noted above. OR
MD a plus AND 2+ years of similar experience noted above
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
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
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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.
