SD/ED Medical Director, FIH and Experimental Medicine

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.

Neurocrine Biosciencesis 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, visitneurocrine.com, and follow the company onLinkedIn,XandFacebook. (*in collaboration with AbbVie)

About the Role:

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• 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 development team

• Provide these functions for specific assigned clinical programs working as a collegiate member of research and development teams for the assigned programs

• Provides clinical leadership in the medical interpretation of the significance of preclinical toxicology findings for early development

• Assist in the identification and selection of clinical research units/sites for 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 clinical studies; if not medically qualified, then works closely with MD experienced in early development

• Oversee the clinical trials program in conjunction with Clinical Operations in accordance with NBI SOPs, Good Clinical Practice, and applicable regulations

• Other duties as assigned

• MD or DO (or equivalent) degree in relevant clinical specialty for the therapeutic area required and 4+ years clinicalexperience with broad bio/pharmaceutical/CRO industry experience in drug development

• Accredited residency training and board certification preferred

• 5yrs Minimum Experience of design of early development programs from a strategic perspective and the clinical interpretation of the significance of preclinical toxicology findings

• 8 yrs Minimum Experience of conduct of Phase I FIH studies/ including Early patient studies, including FIH in patients with a significant component of early-stage experimental medicine to demonstrate target engagement /proof of mechanism or of concept using appropriate technologies and assessments particularly of biological agents requiring initial human investigations in patient populations

• Medically qualified with significant clinical experience including acute medical situations, and possibly specialist level qualification in areas such as clinical immunology, rheumatology or Neurology with focus on neuroimmunology conditions. They may also be qualified by research and clinical experience in Clinical Pharmacology

• Likely to have experience as an early development leader in a team for development programs leading to product approval of novel agents in the inflammation, immunomodulation and immunological areas

• Likely to have people leadership experience of more junior clinicians and non-medical scientists experienced in early development of biological agents in volunteers or patients

• Likely to have PhD or strong research interest in biological /clinical areas such as, pathophysiology of disease areas, specific aspects of early-stage development according to disease area, progression of novel modalities. May have a basic research qualification in immunological sciences or relevant areas of disease biology

• Reports to VP FIH and EM and to Head of Translational Sciences and Biomarkers if US based

• Requires broad, deep and comprehensive expertise in leading-edge theories and techniques for functional area

• Proven ability to translate strategy into tactical plans and drive outcomes

• Must be flexible, adaptable, self-motivated, able to prioritize, and able to manage/progress a large volume of work with minimal supervision

• Strong interpersonal skills and outstanding collaborative skills; proven track record and success in building relationships and having scientific discourse with medical and scientific experts

• Outstanding oral and written communication skills, with close attention to detail; ability to translate complex scientific concepts into simple language tailored for different audiences

• Proficiency with word processing, spreadsheet, database, and presentation software and with filing (archiving) systems

• Deep knowledge and understanding of the drug development process including technical, business, and regulatory issues

• Proven track record working with regulatory agencies and providing clinical leadership for the filing of INDs, NDAs, or other similar government filings

• Strong knowledge of Good Clinical Practice, regulatory procedures relevant to investigational drug development

• Strong knowledge in translational medicine and biomarker evaluation, clinical study execution, regulatory requirements and documents, study design, data analysis, report writing, and scientific presentation of data

• Able to effectively operate in a multi-level matrix corporate environment, requiring interaction with, and/or direction of clinical research project teams, including physicians, scientists, monitors, administrative, regulatory, commercial, and consultant personnel

• Demonstrated success managing interactions with external CROs, consultants and other contract organizations, especially from the context of a small group.

• Has successfully driven program strategy, launch and project management within Clinical Development

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Neurocrine Biosciences is an EEO/Disability/Vets employer.

We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description.

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