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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Acts as the Risk Management Lead at the study level and is responsible for leading the cross functional study team through the development, execution and oversight of study level Risk Management Plans and activities, including:
Identification of protocol specific critical data and processes during protocol development
Identification of risks relevant to protocol specific critical data and processes
Evaluation and ranking of risks
Implementation of risk control strategies
Selection of appropriate Key Risk Indicators and Quality Tolerance Limits to support risk oversight
Guides the study team through planning and execution of RBQM activities for both insourced and outsourced risk management activities in alignment with study objectives, regulatory guidelines, and Neurocrine SOPs
Supports timely issue identification and resolution through data analytics and cross functional collaboration, escalating to senior leaders when applicable
Facilitate risk review meetings and discussions with study team members to effectively communicate and discuss findings and facilitate signal verification, analysis, and mitigation strategies
Supports inspections and internal audits by providing RBQM-related documentation and analysis, in partnership with Clinical Operations and Quality Assurance
Maintains accurate and up-to-date RBQM documentation in the TMF in alignment with GCP requirements and company standards
Identifies opportunities to improve RBQM processes, tools, and ways of working within Clinical Operations and share lessons learned and best practices
Acts as a change agent, champion, subject matter expert, and point of contact for RBQM methodology, leading study teams to understand and follow the best practices to achieve maximum benefit
Participate in cross-functional initiatives, projects, or working groups that support continuous improvement of RBQM and clinical trial oversight practices.
May serve as a mentor to less experienced RBQM colleagues
May be required to support central monitoring activities, including the development of Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and thresholds for central monitoring
May carry out other duties as assigned
BA/BS in life sciences or related discipline or RN AND 6+ years of related industry experience, including experience in drug development, clinical operations or RBQM/Risk Management OR
Master's degree in life sciences or related discipline AND 4+ years of related experience as described above
Ability to interpret clinical trial data and analytics to identify risks and support operational decision-making
Strong organizational and project management skills, with the ability to manage multiple priorities across studies
Ability to work effectively in a matrixed, cross-functional environment and build productive relationships with study team members
Demonstrated ability to follow established processes while identifying practical opportunities for improvement
Proven ability to quickly learn new information and communicate requirements to the appropriate individuals
Effective verbal and written communication skills, including the ability to clearly communicate observations, risks, and recommendations
Strong communication and interpersonal skills with a collaborative mindset and the ability to influence cross functional stakeholders
Solid understanding of Risk Based Quality Management principles and their application within Clinical Operations
Working knowledge of FDA regulations, ICH guidelines, and GCP requirements relevant to clinical trial conduct, oversight, and RBQM
Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
Comfortable developing study specific Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and thresholds for central monitoring
Ability to identify and escalate issues appropriately and follow-through with the corrective actions
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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 $119,700.00-$164,000.00. 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.