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Sr. Medical Director MD, Immunology

Neurocrine Biosciences

San Diego, CAFull TimeStaffH-1B sponsor company
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Location
San Diego, CA
Employment
Full Time
Work model
On-Site
Level
Staff
H-1B history
1 approvals (FY2023)
Posted

About this role

Who We Are

Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, 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 more than 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 , Facebook and YouTube . ( *in collaboration with AbbVie ) At Neurocrine, strong leadership drives both business results and team success. We look for leaders who think strategically, anticipate what’s ahead and set clear direction, while building and empowering high-performing teams. Successful leaders foster an environment where people are motivated to do their best work and deliver meaningful, measurable impact through sound decision-making and accountability.

 About the Role: Medical expert responsible for the development of clinical research strategies and independent direction of Phase 1-3 clinical studies 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. _ 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

Listing verified . Applications go through the company's official careers site.

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