Associate Scientific Director, Clinical Development

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:

A responsible member of the clinical team, dedicated to the development and execution of the clinical and translational strategy and program (scientific, clinical, and operational) of compounds in development. Directs study design, protocol development and execution of clinical research studies in all phases of clinical development through registration (NDA/MAA). Accountable for end-to-end execution of process for each assigned clinical project in a timely and cost-effective manner. Contributes to the interpretation and reporting of clinical study results. Leads multidisciplinary team through complex decisions, integrating input from medical, scientific, regulatory, and commercial perspectives with emphasis on clinical trial methodology, management and development of outcome measures and will also be a resource to program teams for guidance of all matters related to analysis and communication of clinical data. May also participate in the evaluation of business development including licensing opportunities.

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

• Responsible member of the clinical team, dedicated to the development and execution of the clinical strategy and program (scientific, clinical)

• Providing clinical support and scientific opinion to study teams and functional areas such as regulatory, clinical operations and line management

• Provides input to study design, protocol concepts/protocols preparation, statistical analysis plans, and reporting within assigned programs to yield high value clinical endpoint insight for future critical decisions

• 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

• Contributes to and manages the development of the clinical development plan, Investigator’s Brochures, clinical study protocols, clinical study reports, regulatory documents, and other critical clinical study documents, etc. for each clinically assigned project or program in close collaboration with the Clinical Leaders and in partnership with supporting departments

• Leverages personal subject matter experience, and conducts research into relevant literature, to identify most optimal clinical assessments and outcomes for inclusion in clinical trials

• 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

• Works with study and program teams to achieve program goals and provides deliverables in approved timeframes

• Monitors patient data and study-related information related to clinical study sites and clinical trial participation, including data science approaches

• Ensures the investigator adheres to