Sr. Manager Document & Clinical Systems

Neurocrine Biosciences

US CA San Diego Onsite Clinical Group

About this role

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)

At Neurocrine, strong leadership drives both business results and team success. We look for leaders who think strategically, anticipate what’s ahead and set clear direction, while building and empowering high-performing teams. Successful leaders foster an environment where people are motivated to do their best work and deliver meaningful, measurable impact through sound decision-making and accountability.

About the Role:

Responsible for leading the strategy, oversight, quality, compliance, and operational execution of the electronic Trial Master File (eTMF) across one or more clinical development programs. Serves as the TMF subject matter expert (SME) and works cross-functionally with Clinical Operations, CROs, Functional Areas, Quality Assurance, Regulatory Affairs, and Clinical Systems to ensure TMFs are inspection-ready throughout the lifecycle of each study.

Provides leadership for TMF processes, vendor oversight, inspection readiness, metrics, training, and continuous process improvement while ensuring compliance with ICH-GCP, FDA, EMA, MHRA, and other global regulatory requirements.

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

Leads, mentors, and develops junior team members by providing performance management, coaching, onboarding, training, and career development while ensuring successful delivery of study and departmental objectives
Provides strategic leadership and oversight for TMF operations across assigned clinical studies, ensuring timely, compliant, and inspection-ready TMFs through effective document management, quality review, remediation, and query resolution
Serves as the eTMF Subject Matter Expert (SME), providing strategic and technical guidance to study teams, functional areas, CROs, vendors, and end users while promoting TMF best practices and regulatory compliance
Establishes and monitors departmental priorities, work plans, schedules, resource allocation, and key performance indicators to ensure achievement of business objectives and study milestones
Builds and maintains strong cross-functional partnerships with Clinical Operations, Regulatory, Biometrics, Pharmacovigilance, Clinical Supply, CROs, vendors, and other stakeholders to support successful TMF execution
Leads TMF governance and study team meetings, proactively communicating risks, quality concerns, compliance issues, and recommendations to study teams and senior leadership
Oversees TMF quality through health checks, performance metrics, trend analysis, and continuous process improvement initiatives, including development of SOPs, work instructions, training materials, and sharing of lessons learned
Leads internal and external audit and inspection readiness activities, including facilitating inspections, preparing responses, overseeing CAPAs, and ensuring timely resolution of TMF findings
Applies expert knowledge of ICH-GCP, global regulatory requirements, industry standards, and TMF best practices to ensure ongoing compliance and operational excellence
Supports departmental and organizational initiatives, special projects, and other responsibilities as assigned

Requirements:

BA/BS degree in life sciences or related field AND 8+ years experience in clinical trial documentation, clinical operations, or related areas. Previous experience as a Clinical Trial Associate [CRA], Clinical Trial Manager [CTM], Research Coordinator or similiar strongly preferred. OR
Master's degree in life sciences or related field AND 6+ years experience as noted above
Extensive experience in maintaining TMF documents and coordinating cross-departmental collaboration
Excellent computer skills
Advanced problem-solving and analytical thinking skills
Ability to meet multiple deadlines, with a high degree of accuracy and efficiency
Strong collaboration skills, with a track record of effectively leading and supporting cross-functional teams
Excellent communication and interpersonal skills, with the ability to work effectively with internal and external stakeholders
Comprehensive understanding of regulatory requirements and standards in the biopharmaceutical industry, with a commitment to ongoing learning and professional development
Excellent organizational skills and detail oriented
Strong leadership in both team settings and independent projects, effectively managing direct reports with a coaching approach that helps junior team members develop their skills and advance their careers
Comprehensive project management expertise, including resource allocation, timeline governance, and risk mitigation strategies
Strong knowledge of Clinical Operations, specifically conducting clinical studies from start-up through close-out
Expertise in audit/inspection-related activities, Good Clinical Practices(GCP), and regulatory compliance, and inspection readiness

#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 $154,500.00-$211,000.00. 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.