Executive Director, Medical MD, Endo
Neurocrine BiosciencesAbout the role
Who We Are:
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)
About the Role:
Drives strategic organizational plans and policies for clinical trials/research and data collection activities. Works with a multidisciplinary team involving R & D project teams, clinical project managers, business management, regulatory, and others to execute trials Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. May recruit clinical investigators and negotiate study design and costs. Responsible for directing human clinical trials, phases I – IV, for company products under development. Responsibilities also include adverse event reporting and safety responsibilities monitoring. Coordinates and develops information for reports submitted to regulatory or other agencies. Monitors adherence to protocols and determines study completion._
Your Contributions (include, but are not limited to):
Drive strategic direction for organizational plans and policies for clinical trials/research and data collection activities. Responsible for the implementation of clinical projects
Drive the preparation of clinical development projects and initiatives and IND sections for pre-IND projects to ensure effective operations and the achievement of company objectives
Create and foster strong relationships with investigators
Collaborates with senior management in the development of strategies, research plans, budgets, and clinical summaries
Ensure appropriate updates of Investigators Brochures
Monitor adherence to protocols
Supervise the organization of monitoring procedures and collection of data
Monitor clinical trials directly and indirectly through assigned CRAs and CROs
Provide necessary input for FDA documents
Participate on multidisciplinary project teams
Participate in and speak at professional meetings
Prepare final study reports
Anticipate factors that could impact Neurocrine's strategies and its position in the f
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