Sr. Specialist, Clinical Trials

Neurocrine Biosciences, Inc.; San Diego (CA); On-site; USD 111,000 - 151,000; Full time

Job summary

Neurocrine Biosciences, Inc. is seeking a Senior Clinical Trials Operations Lead to support planning, initiation, conduct, and close-out of assigned clinical studies (domestic and global).

The role collaborates with CTMs and CROs to ensure studies adhere to FDA regulations, ICH guidelines, and internal SOPs. You will develop study timelines, contribute to recruitment efforts, and help monitor and guide study activities across programs.

Qualifications

• BS/BA in Scientific field or equivalent with 4+ years of clinical trials/operations experience preferred.
• Master's in Scientific field or equivalent with 2+ years experience.
• Knowledge of FDA regulations, ICH, GCPs, EU Directives.
• Experience coordinating with CROs and internal teams.
• Strong analytical and problem-solving skills.

Responsibilities

• Partner with CTMs to ensure trials comply with FDA regulations, EU Directives, ICH guidelines and SOPs.
• Lead smaller studies and act as team member for assigned studies.
• Develop reports and provide insights for study design discussions.
• Manage project plans, tracking metrics, issues lists and CRO/CSP oversight.
• Lead or participate in study team meetings; create timelines aligned with corporate goals.

Skills

Clinical trial management

FDA regulations

ICH guidelines

CRO oversight

Project coordination

Education

BS/BA in scientific field

Master's degree in scientific field

Job description

Who We Are:

Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, 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 more than 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 , Facebook and YouTube . ( *in collaboration with AbbVie )

About the Role:

Leads efforts to support the operational activities for planning, initiation, conduct and close out of assigned Clinical Studies (domestic and global studies). Key contributor to clinical studies using Contract Research Organizations (CROs) and internally run studies.

Your Contributions (include, but are not limited to):

• Partnering with the Clinical Trial Managers (CTM), ensures 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


• Serves as lead on smaller studies and/or team member for of assigned clinical studies


• Develops reports and provide insights for technical and study design discussions


• Manages projects plan, tracking metrics, issues lists and resolution for contract research organizations (CROs) and other contract service providers (CSPs) for assigned studies


• Participate in and leads some study team meetings. Working with CTM, creates study timelines in accordance with corporate goals. Helps with recruitment efforts


• Participates (may lead smaller) in internally run studies (without CROs) including creating draft monitoring plans, documenting on-site monitoring guidelines, forms, tools and participate in onsite monitoring and co-monitoring visits, as necessary


• Works collaboratively with clinical operations department in documenting NBI standard processes across assigned clinical programs. May train lower level Specialists


• Other duties as assigned

Requirements:

• 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


• 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

Job Specific Knowledge & Qualifications:

• 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

#LI-RS1

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 $110,800.00-$151,000.00. 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, th