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 Biosciences is 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, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (*in collaboration with AbbVie)
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Strategizes and oversees clinical in-use studies to assess material compatibility, in-use shelf life, and define the appropriate clinical handling procedures for investigational products
Design, author, and oversee the execution of Pharmacy Manuals supporting early-phase clinical trials
Contributes to clinical protocol design, amendments, and execution of studies assessing dosing, administration, and product handling
Apply advanced scientific principles to complex challenges in product development lifecycle encompassing definition, optimization, characterization, and validation
Plans and manage projects. Represents development in cross-functional teams
Maintains accountability for deliverables including production plans for development projects
Independently designs, plans and executes advanced activities towards the goals of one or more development projects to support preclinical through commercial activities
Supervises laboratory work and/or lab personnel and ensures safe laboratory practices
Proactively identifies process or product challenges and drives necessary optimization activities including trouble-shooting experimentation
Identifies and recommends novel approaches to improve product quality, product stability, or to achieve cost effectiveness
Manages contract manufacturing activities and directly interacts with contractors
Author or contribute to clinical protocols, study reports, regulatory briefing documents, and responses to health authority questions
May provide supervision of laboratory personnel and guidance for their professional development
Build and enhance internal and external professional relationships
Other duties as assigned
BS/BA in pharmacy, pharmaceutical sciences, chemistry, biochemistry, biology, or similar scientific discipline and 8+ years of experience in formulation research, clinical research, experience managing laboratory, maximizing productivity is desirable OR
MS/MA in pharmacy, chemistry, biochemistry, biology, or similar scientific discipline and 6+ years of similar experience noted above OR
PharmD or PhD in Pharmaceutical Sciences or similar scientific discipline and 4+ years of relevant experience; may include fellowships in academia or industry
Experience supporting clinical trials, especially in-use/actual-use studies
Familiarity with clinical protocol development, amendments, and clinical study reports
Good understanding of GCP, GLP, and relevant FDA/ICH guidance
Experience with patient handling, usability, or human factors is a plus
Experience working in a regulated environment
Excellent laboratory and productivity skills
Experience working with CROs, clinical sites, investigators, and external vendors is a plus
Demonstration of cross-functional understanding related to drug development
Advanced knowledge and demonstrated ability to work with / recommend a variety of laboratory equipment/tools
Maintains broad knowledge of scientific principles and theories and possesses intellectual mastery of one or more scientific areas
Develops and drives creative solutions to technical challenges
May develop an understanding of other areas and related dependencies
Ability to work as part of and lead multiple teams
Exhibits leadership skills, typically leads junior levels and/or indirect teams
Excellent interpersonal communications, problem-solving, and analytical thinking skills
See broader picture, impact on multiple programs, teams and/or departments
Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
Excellent project management skills
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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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The annual base salary we reasonably expect to pay is $130,800.00-$179,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.