SD/ED Medical Director, FIH and Experimental Medicine

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:

Medical expertise responsible for leading, with expert knowledge of early development, Phase 1 (e.g. FIH and Experimental Medicine) clinical studies which may be in healthy volunteers or patient populations as part of the early development of Neurocrine compounds. Experience with biomolecules, such as therapeutic antibodies, is required.
Role requires close interaction with Therapeutic Area Research and Clinical Development staff to align on scope, strategy and study designs. Close collaboration within cross-functional project teams (clinical project managers, preclinical/clinical pharmacology, biometrics, regulatory, drug safety) to ensure efficient study design, approval and execution. Share and apply knowledge and expertise across the development organization.

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

• Provide early development advice, consulting and clinical leadership in decisions during the design, execution, oversight, analysis, and reporting of FIH/Phase 1 clinical studies

• Provide early development advice, consulting and clinical leadership into the regulatory submissions and responses as part of the regulatory authorization process for clinical studies under responsibility of the individual

• Through understanding of the challenges of recruitment and assessment of different patient populations, assist in identification of the most efficient patient populations for early development studies of safety, tolerability and pharmacodynamics, particularly when studies in healthy volunteers are contra-indicated on safety grounds

• Contribute to the evaluation of therapeutic area projects in discovery research. Provide strategic leadership in clinical contributions to the selection of new projects regarding readiness for clinical testing

• Works with research and biomarker scientists to develop a translational plan for early progression and assessment of novel entities in the therapeutic area space. Identifies key early development decision check points and provides this leadership to the project deve