Clinical Trials Manager

Who We Are:

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.

What We Do:

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:

Join our dynamic team as a Clinical Trials Manager, where you will lead and oversee the operational activities to support the planning, initiation, conduct, and successful closeout of both domestic and global clinical studies. You'll play a pivotal role in managing studies using Contract Research Organizations (CROs) as well as handling internally run studies, ensuring the highest standards of excellence and compliance every step of the way. If you're passionate about making a real impact in the world of clinical research and have prior gene therapy experience as well as Phase I first in human clinical trials we would love your expertise! Be a part of our innovative and collaborative environment at Neurocrine!

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Your Impact (will include, but not limited to):

• Ensure rigorous compliance with FDA regulations, EU Directive, ICH guidelines, and NBI SOPs and policies in the execution of clinical studies

• Serving as the primary conduit for all clinical operations facets of designated clinical studies

• Engage in strategic technical and study design dialogues in first in human and gene therapy trials, offering valuable input to clinical trial outlines, protocols, and clinical study reports

• Proficient managing CROs and other contract service providers for assigned studies, ensuring seamless collaboration and adherence to corporate standards

• Spearhead study team meetings and adeptly addressing study issues, crafting and overseeing study timelines aligned with corporate objectives, and devising effective recruitment strategies to surmount enrollment barriers

• Directly overseeing internally run studies (sans CROs), including the management of CRAs, development of monitoring plans and tools, and conducting on-site monitoring and co-monitoring visits as necessary

• Collaborate seamlessly with the clinical operations department to develop, implement, and uphold NBI standard processes across all clinical programs

• Fulfill additional responsibilities as delegated, contributing to the synergy and success of our pioneering clinical research efforts at Neurocrine!

Requirements:

• BS/BA degree and 8+ years of clinical trial management experience, including CRO/vendor management (domestic and international), monitoring of budget scope, clinical site monitoring or related experience required OR

• Masters and 6+ years of related experience

• Must have detailed knowledge of clinical drug development process including working knowledge of ICH, Good Clinical Practices (GCPs), FDA regulations, and EU Directive

• Excellent knowledge of clinical operations in gene therapy and Phase I trials, specifically conducting clinical studies from start-up through close-out

• Broad trial management protocol and process knowledge

• Strong understanding of Clinical Research industry and the relevant environments in which it operates

• Ability to identify and organize clinical resources needed to accomplish tasks, set objectives and provide clear direction to others; experience planning activities in advance and taking account of possible 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

• 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

• Proven ability to work through others to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback; experience productively partnering cross functionally and with customers to advance work effectively and efficiently

• Proven ability at analyzing data and information to derive conclusions and drive sound decision making

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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 dont 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 $128,200.00-$185,900.00. 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.