Manager, Bioanalytical Regulatory

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: Oversees multiple bioanalytical functions at contract research organizations (CRO) according to project-relevant regulatory requirements and industry standards. Experience supporting bioanalytical method development, validation, and sample analysis across multiple modalities in a non-GLP and/or GLP environment. Responsible for overseeing thedevelopment and validation of highly sensitive and specific bioanalytical methods for quantitative analysis of new chemical entities, metabolites, and biomarkers in a variety of biological matrices at CROs.-. Contribute to long-term strategic planning to enable the growth and enhance productivity of the bioanalytical efforts within the regulatory space. Act as primary point of contact for certain DMPK bioanalytical efforts. Serve as a bioanalytical Subject Matter Expert (SME) on preclinical and clinical teams, and provide mentorship to and frequently supervise the day-to-day work of junior team members. _ Your Contributions (include, but are not limited to): Provide oversight of bioanalytical CROs to facilitate the transfer, development, and validation of regulated (GLP/GCP) bioanalytical methods and ensure quality data and reports are delivered within specified timelines Initiate and manage contracts, coordinate activities with select CROs in the areas of pharmacokinetics, toxicokinetics, dose formulation analysis, immunogenicity, and biomarker Contribute to the preparation or review of study protocols, Clinical Study Reports and regulatory documents and interactions to support INDs, BLAs, RFMs, IRs and address relevant queries from regulatory agencies Conduct CRO evaluation and selection, review CRO SOPs, determine additional bioanalytical requirements as needed, and perform regular site visits and inspection Technical monitoring during bioanalytical method development, validation, and sample analysis; overseeing method transfer between CROs; reviewing validation reports and experimental documentation; and archiving relevant study documents Participates in or leads the development of strategic project / group goals, practices and methods Leads projects and teams for the analysis of in-vivo and ex-vivo studies to support pharmacokinetics(PK) and toxicokinetics (TK) studies Develops and implements novel methodologies to characterize DMPK properties and exposures of drug candidates and/or biomarkers Acts as a