Sr. Medical Director (MD), Translational and Experimental Medicine, Metabolic

About the role

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 patients with 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 ) Medical expert responsible for the development of translational and early clinical research strategies and independent direction of Phase 1 and early Phase 2 (first-in-human and early proof-of-concept) clinical studies while working with cross-functional project teams (clinical project managers, preclinical/clinical pharmacology, biometrics, regulatory, drug safety). Responsible for the creation and execution of early clinical development plans that advance innovative therapies, particularly in metabolic disorders including but not limited to disorders affecting the endocrinological, immunologic, and/or neurologic systems. Provides expert medical and scientific advice to advance the early development portfolio and help navigate the complex translational drug development landscape. Works closely with Research and Preclinical Development to develop and implement biomarkers and experimental medicine approaches necessary for effective evaluation of novel molecules in early human studies. _ Your Contributions (include, but are not limited to): For assigned programs, develops translational and early clinical development strategies and is accountable for the study design of Phase 1 and early Phase 2 clinical trials, leading preparation of clinical study synopses and serving as a major contributor to the writing of protocols/major amendments, the design of data collection systems, interpretation of clinical and biomarker data, and 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 Translational Medicine Lead. Accountable and responsible for the medical input to integrated development plans prepared by the Program Team, with primary emphasis on first-in-human and early proof-of-concept strategies Provides medical leadership to the Program Team and is accountable for driving execution of the early clinical development plan Develops and implements study protocols in conjunction with a multidisciplinary Development Team, incorporating mechanistic endpoints, target engagement measures, pharmacodynamic assessments, and biomarker strategies to interrogate drug action in humans Partners closely with Research and Preclinical Development to translate preclinical pharmacology, disease biology, and mechanistic hypotheses into early clinical testing strategies, including dose selection and PK/PD modeling approaches Assist in the identification and selection of clinical investigators for early phase 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 early clinical studies Oversee the early clinical trials program in conjunction with Clinical Operations in accordance with NBI SOPs, Good Clinical Practice, and applicable regulations Identify resource requirements, lead budget planning and personnel forecasting for early clinical research programs; contribute to recruitment, training, and development of clinical teams and identify/select clinical consultants as needed Lead the analysis, interpretation, and presentation of results of assigned early clinical studies to internal and external audiences, with emphasis on translational insights and data-driven decision making Work with Medical Affairs and external opinion leaders to secure new collaborators and present early translational and proof-of-concept results Interface with Research, Product Development, and Business Development to assess new product opportunities and develop translational and early clinical re

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