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)
About the Role:
Leads efforts to support the centralized operational activities for assigned Clinical Studies. Centralized activities can include but are not limited to set up of studies, development of Informed Consent documents and study plans, handling IRB submissions of protocol/ICF/sites, management of the Trial Master File (TMF) and Financial Disclosure Forms, feasibility and selection of sites, coordination of committees (i.e. adjudication committees), support of site enrollment, and oversight of monitoring for studies outsourced to Contract Research Organizations (CROs)._
Ensures that centralized activities for clinical studies are conducted in compliance with Food and Drug Administration (FDA) regulations, EU Directive, International Conference on Harmonization (ICH) guidelines, and NBI Standard Operating Procedures (SOPs) and policies
Works collaboratively with assigned study teams in developing, implementing and ensuring NBI standard processes across clinical programs
Supports best practice and improved operational processes for execution of clinical trials
Supports the development of processes, tools, templates, and applicable training related to centralized activities and/or monitoring oversight
Supports generating metrics and reports to provide insights into cycle time for centralized activities and/or oversight of outsourced monitoring activities
Works collaboratively with clinical operations department in documenting NBI standard processes across assigned clinical programs. May train and provide guidance to lower level Specialists
Supports inspection readiness activities
Other duties as assigned
BS/BA in Scientific field or equivalent and 4+ years of clinical trials or operations experience, CRO/Vendor Management exposure is preferred. Participation in monitoring clinical trials or related experience required OR
Master's degree in Scientific field or equivalent and 2+ years of similar experience noted above
Strong knowledge of the clinical drug development process including working knowledge of ICH, Good Clinical Practices (GCPs), FDA regulations, and EU Directives
Solid understanding of clinical operations, specifically conducting clinical studies from start-up through close-out
Trial management protocol and process understanding
Solid understanding of Clinical Research industry and the relevant environments in which it operates
Ability to design, plan and execute activities and works well under changing circumstances; manages time effectively
Has knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines
Works to improve tools and processes within functional area
Ability to work as part of team and may train lower levels
Excellent computer skills
Strong communications, problem-solving, analytical thinking skills
Sees impact on department and clinical function
Ability to meet multiple deadlines across a project/program, with a high degree of accuracy and efficiency
Strong project management skills
Ability at analyzing data and information to derive options/recommendations for management considerations
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.
_
The annual base salary we reasonably expect to pay is $108,600.00-$148,000.00. 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 20% 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.