Clinical Compliance Manager

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 patients with 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:

Independently leads and collaborates with Clinical Operations (ClinOps) to drive strategic initiatives related to clinical process compliance, continuous improvement, and inspection readiness. Plays a pivotal role in shaping and implementing process enhancements, including study-specific training programs and management of NBI consent document templates. Oversees the facilitation of training and the creation and revision of controlled documents to ensure operational excellence. Serves as a key ClinOps liaison, adept at identifying procedural gaps and championing innovative solutions to enhance efficiency and effectiveness across clinical processes. _

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

Guides study teams on audit/inspection activities, offering insights on findings, and escalating issues to Clinical Compliance (CC) Director when necessary

Serves as the ClinOps point person, providing key advice on clinical processes and Good Clinical Practices (GCP)

Develops and reviews new or updated ClinOps controlled documents, coordinate input from Subject Matter Experts (SMEs), assess impact, propose implementation plans, and manage timelines

Leads process integration and collaboration with vendors (e.g., CROs)

Oversees the management and updating of NBI consent document templates and related documents

Collaborates with NBI Drug Safety and Pharmacovigilance (DSPV) to ensure compound risk language is accurately included in consent documents

Manages and oversees Study-Specific Training (SST) activities, such as maintenance SST matrix templates, processing of document submissions for SST assignments, and compliance with SST processes

Manages SST system solution implementation, updates and user access.

Manages ClinOps training activities, including developing training materials and conducting live training sessions under guidance from CC Director

Oversees the distribution lists (DL) management process (e.g., ensure DLs for internal distribution of safety reports are created and all applicable study team members are listed prior to the first study participant is screened)

Oversees ClinOps training curriculum reviews, making sure controlled documents are assigned appropriately for training based on roles and consulting with group leads when necessary

Participates and promotes collaboration in departmental and cross-departmental meetings, as necessary

Develops and maintains working relationships with other functional areas outside of Clinical Operations

Demonstrates knowledge of applicable regulatory requirements, and business standards

Constantly maintains knowledge in an on-going manner

Performs other duties as assigned

Requirements:

BS/BA degree in life science or related field AND 6+ years of experience in Clinical Compliance, Clinical Operations, or related areas within the biopharmaceutical industry. Previous experience as a Clinical Trial Associate (CRA), Clinical Trial Manager (CTM) or Clinical Research Coordinator, or equivalent, preferred OR

Master’s degree life science or related field AND 4+ years of similar experience noted above

Proven expertise in audit/inspection-related activities, Good Clinical Practices (GCP), and regulatory compliance, and inspection readiness

Strong leadership and 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

Extensive experience in maintaining controlled documents, managing training activities, and coordinating cross-departmental collaboration

Comprehensive understanding of regulatory requirements and standards in the biopharmaceutical industry, with a commitment to ongoing learning and professional development

Excellent organizational skills and be detail oriented

Proficiency in both collaborative and independent work, with the capability to mentor and lead junior team members

Comprehensive project management expertise, including resource allocation, timeline governance, and risk mitigation strategies

Excellent computer skills. Experience with Veeva Vault preferred

Working knowledge of Clinical Operations, specifically conducting clinical studies from start-up through close-out

Advanced problem-solving and analytical thinking skills

Ability to meet multiple deadlines, with a high degree of accuracy and efficiency

#LI-SA

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 $130,800.00-$179,000.00. 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.