Scientific Director, Clinical Development

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

• Providing recommendations to and expertise to study teams and functional areas such as regulatory, clinical operations and line management

• Creates 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 assessment of established and the development of novel outcome measures in the context of clinical trials in early and late stages of clinical development

• 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

• Uses subject matter experience to influence clinical teams, conducts research into relevant literature, identify most optimal clinical assessments and outcome measure 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

• Manages and supports study and program teams to achieve program goals and provides deliverables in approved timeframes

• Provides timely and accurate monitoring of all study data (patient data, clinical site data, source documents, etc.)

• Leverages data analytics and data science approaches in a cross-functional manner to produce insights before (e.g. modeling), during (e.g. blinded analytics), and after (e.g. post-hoc analysis) a clinical study

• Monitors the investigator adherence to research protocols, regulatory requirements and good clinical practices and provides input into data validation plan

• Monitors study sites and audit facility selection; including site visits as needed

• Implements best regulatory practices and drug development precedent to assigned programs

• Provides recommendations of development of regulatory documents for filings and agency meetings

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

• Proactive identification of issues/problems and recommends solutions

• Directs and manages team members to prepare abstracts, manuscripts, and presentations for external meetings as well as author clinical sections of regulatory documents (IB, IND sections)

• Remains up-to-date with current information on pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities

• Maintains knowledge of ICH-GCP, external regulations and procedures - required for regulatory filing

• Liaises with bioanalytical laboratories, pharmacokinetic scientists, biomarker representatives and data managers to ensure key PK, PD and clinical safety data are available when needed for critical Clinical Team decisions

• Liaises with statisticians and programmers to help develop and implement the statistical data analysis plans

• Evaluates and selects clinical study research centers and appropriate investigators - in collaboration with Experimental Medicine Clinical Leaders (Phase 0 to Phase 2a), and the Research and Development Organization (Phase 1b/2a studies)

• Leads clinical support for Regulatory Affairs activities for a clinical program (e.g., health authority documents/responses, labeling, filing activities)

• Collaborates/assists with safety responsible physicians in medical monitoring and evaluation of adverse events in clinical trials

• Provides guidance to the interpretation and reporting of clinical research results

• Prepares presentations, medical publications, etc emerging from the team and its affiliates

• Creates and manages the budget for all project related activities (internal and external partners) of each individually assigned project

• Subject eligibility review

• Other duties as assigned

• BS/BA degree in Biology, Chemistry, or related science field and 15+ years of relevant experience OR

• Master's in Biology, Chemistry, or related science field and 13+ years of related experience OR

• PhD or equivalent combination of education and work experience and 7+ years of related experience

• Has knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines

• Strategic skills thinking skills with the ability to formulate, develop and execute clinical strategies

• Works to improve tools and processes within functional area

• Develop reputation inside the company as it relates to area of expertise

• Ability to work as part of and lead multiple teams

• Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams

• Excellent communications, problem-solving, analytical thinking skills

• Ability to see the broader picture and impact on multiple departments/divisions

• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency

• Excellent project management skills

• Excellent computer literacy

• Assimilates data and research findings outside of Neurocrine for application to new scientific projects.

• Maintains substantial knowledge of scientific principles and theories and possesses intellectual mastery of one or more scientific areas.

• May develop an understanding of other areas and related dependencies.

• Advanced knowledge and demonstrated ability working with / recommending a variety of laboratory equipment/tools.

• Knowledge, experience, and skills typically developed by a strong track record of accomplishment in the field of translational research in Neuroscience.

• Experience in developing medicines for neurological disorders, and/or neurodegenerative, neuro-pediatric, or rare neurological disease

• Experience in the design and conduct of Phase I/2/3 studies in Neuroscience.

• Experience in gene therapy drug development

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Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.

We are committed to building a diverse, equitable, and inclusive workplace, 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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