Sr. Medical Director, MD- (Neuropsychiatry)

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, but few options.

What We Do:

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, visit neurocrine.com, and follow the company on LinkedIn, X (Formerly Twitter) and Facebook. (*in collaboration with AbbVie)

About the Role:

Medical expert responsible for the development of clinical research strategies and independent direction of Phase 1-3 clinical studies in the Neuropsychiatry therapeutic area while working with a cross-functional project teams (clinical project managers, preclinical/clinical pharmacology, biometrics, regulatory, drug safety) creation and execution of clinical development plans and in the development of strategies that will ultimately lead to approvals of Neurocrine's products. Provide expert medical advice to advance the development portfolio and will help the company navigate the complex drug development landscape. Works closely with Research and Preclinical Development to develop biomarkers necessary for the most effective evaluation of novel molecules in early clinical development.

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Your Contributions (include, but are not limited to):

• For assigned programs, develops clinical development strategies and accountable for the study design of clinical trials in Development, leading on the preparation of clinical study synopses and being a major contributor to the writing of protocols/major amendments, the design of data collection systems, interpretation of clinical data, and the preparation of final clinical study reports. Engages with external experts and organizations as needed to achieve these aims

• Represents Medical/Clinical on the cross-functional Program Team as the Program/Therapeutic Medical Lead. Accountable and responsible for the medical input to integrated development plans prepared by the Program Team and the clinical development plans that underpin them. Collaborate cross-functionally to support medical activities for clinical studies

• Provides medical leadership to the Program Team. Accountable and responsible for driving the execution of the clinical development plan

• Develops and implements study protocols in conjunction with a multidisciplinary Development Team

• Assist in the identification and selection of clinical investigators for clinical trials and maintain appropriate communication and professional relationships as Sponsor medical monitor/representative

• Conduct medical assessment and disposition of adverse events (in conjunction with Drug Safety physician) and evaluate safety of clinical compounds prior to and during ongoing clinical studies

• Oversee the clinical trials program in conjunction with Clinical Operations in accordance with NBI SOPs, Good Clinical Practice, and applicable regulations

• Identify resource requirements, leads budget planning and personnel forecasting for clinical research programs; key contributor in the recruitment, training and development of the clinical teams, as well as Identify and select clinical consultants as needed

• Leads the analysis, interpretation, and presentation of results of assigned clinical studies to internal and external audiences

• Work with Medical Affairs and external o