Assoc. Scientific Director, Translational Medicine- (Onsite)

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:

Collaborate with cross functional teams to evaluate therapeutic targets, build translatable biomarker strategies, and establish robust clinical development plans. Lead clinical biomarker efforts through vendor selection, method development/validation, integration into clinical protocols, execution of sample testing at CROs, and biomarker data analysis/interpretation. The individual will have a strong strategic role on project teams responsible for translating preclinical research into clinical programs through influencing IND data packages, interacting with the FDA/EMA, building relationships with KOLs.

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

• Establishes translational neurology plans for designated programs and participate with senior management to align biomarker strategies to program goals to enable data-driven decisions

• Provides disease biology expertise to clinical study teams and functional areas such as regulatory, clinical development, and clinical operations

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

• Collaborates with external opinion leaders. internal clinicians, research scientists and clinical operations to ensure appropriate biomarkers are incorporated within clinical studies validated appropriately for their intended use

• Support identification and development of novel biomarker platforms

• Engage with CROs to develop and validate clinical biomarker assays in a fit-for-purpose manner

• Manages clinical biomarker data delivery and analysis and associated timelines by working with relevant internal functions and CROs

• Reviews and interprets scientific knowledge of competitor landscape (molecule / indication)

• Participate with team members to prepare abstracts, manuscripts, and presentations for external meetings as well as author biomarker sections of regulatory documents (IB, IND s