Director, Clinical Development

About the role

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. What We Do: 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. _ Your Contributions (include, but are not limited to): 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