Principal Scientist, Clinical Development - Psych

Neurocrine Biosciences • San Diego, CA

1d

About The Position

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company 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. This role leads projects related to early clinical development and implements plans based on the translational strategy for new medicines, supporting development through late phases and registration. Responsibilities include clinical development for study design, development, execution, data readout, and summary of early phase studies in support of late-phase development to NDA/MAA submissions in Neuroscience. The role may lead a multidisciplinary team through complex decisions, integrating input from medical, scientific, regulatory and commercial perspectives with emphasis on clinical trial methodology, management and development of outcome measures. The role may also serve as a resource to program teams for guidance on all matters related to the analysis and communication of clinical data, and may participate in the evaluation of business development, including licensing opportunities.

Requirements

• BS/BA degree in Biology, Chemistry, or related science field AND 6+ years of relevant experience, or OR Master’s in Biology, Chemistry, or related science field AND 4+ years of related experience, or OR PharmD or PhD AND 2+ 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
• Developing 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 computer skills
• Excellent communications, problem-solving, analytical thinking skills
• Sees broader picture, 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.
• May develop an understanding of other areas and related dependencies
• Knowledge, experience, and skills typically developed by a strong track record of accomplishment in the field of translational research in Neuroscience.
• Advanced knowledge in developing medicines for Mood Disorders, Schizophrenia and other psychiatry diseases
• Demonstrated expertise in the design and conduct of Phase I/2/3 studies in Neuroscience
• Advanced knowledge and demonstrated ability working with / recommending a variety of laboratory equipment/tools
• 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

Responsibilities

• Implements operational plans based on established strategic plans for designated products/programs and provide input on alignment of objectives across the organization; develop methods, techniques, and evaluation criteria for projects and programs
• Recommends planning of scientific aspects of early clinical development trials
• Providing clinical support and scientific opinion to study teams and functional areas such as regulatory, clinical operations and line management
• Provides input to 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
• Contributes within clinical development program teams on selection of established and development of novel outcome measures in the context of clinical trials in early and late stages of clinical development
• Leverages personal subject matter experience, and conducts research into relevant literature, to identify most optimal clinical assessments and outcomes 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
• Works with study and program teams to achieve program goals and provides deliverables in approved timeframes
• Monitors patient data and study-related information related to clinical study sites and clinical trial participation
• Ensures the investigator adheres to research protocols, regulatory requirements and good clinical practices and provides input into data validation plan
• Provides timely and accurate monitoring of patient data and study-related information from source documents, research records, and site visits where applicable. May monitor study sites and audit facility selection
• Applies best regulatory practices and drug development precedent to assigned programs
• Supports the 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
• Participate with 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
• Other duties as assigned

Benefits

• retirement savings plan (with company match)
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Number of Employees: 501-1,000 employees