Sr. Specialist, Clinical Trials

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

Benefits offered by this job

Annual bonus

Equity program

Health benefits

Retirement plan

Job summary

Neurocrine Biosciences is seeking a Clinical Trials professional to lead operational activities for planning, initiation, conduct and close-out of assigned studies (domestic and global). You will work with CTMs, CROs, and CSPs to ensure studies run in compliance with FDA regulations and ICH guidelines.

The role emphasizes project management, data analysis, and collaboration across functional teams, with responsibilities for timelines, monitoring plans, and recruitment support.

Qualifications

• BS/BA in a scientific field with 4+ years of clinical trials or operations experience.
• Master’s degree in a scientific field with 2+ years of related experience.

Responsibilities

• Partner CTMs to ensure FDA/ICH/GXP compliance across studies.
• Lead on smaller studies or contribute as team member.
• Develop reports and provide insights for study design discussions.
• Manage project plans, metrics, and CRO/CSP performance for assigned studies.
• Participate in study team meetings and assist with recruitment efforts.

Skills

Clinical trials

CRO management

FDA regulations

ICH guidelines

Project management

Data analysis

Cross-functional

Communication

Education

BS/BA in science

Master’s in science

Tools

None

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

• 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

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.

Compensation & Benefits

• 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, 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.

We are a top place to work. Neurocrine Biosciences was named one of the FORTUNE Best Workplaces in Biopharma™ 2025. We were also named a Great Place to Work® Certified company.

Our Values

• PASSION: We are driven and love what we do. We are committed to our goals and to making a difference.
• INTEGRITY: We do the right thing for patients and our community. We take accountability. We speak up.
• COLLABORATION: We trust one another. We are inclusive. We are respectful. We are transparent. Together we succeed.
• INNOVATION: We seek and create optimal solutions.
• TENACITY: We do not quit. We adapt. We accomplish what others cannot.

Come join our team during this exciting time of growth and opportunities!