AD, Biomarker Operations

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.

Neurocrine Biosciencesis 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, visitneurocrine.com, and follow the company onLinkedIn,XandFacebook. (*in collaboration with AbbVie)

About the Role:

_

Your Contributions:

• Collaborate closely with esteemed biomarker scientists and clinical teams to craft innovative biomarker strategies for high-impact clinical trials. Your role will involve selecting cutting-edge assay platforms, defining precise assay parameters, and creating detailed sample collection protocols that push the boundaries of scientific discovery.

• Serve as the ultimate authority in at least one technical area, providing your expertise to guide the CRO independently on vital tasks such as biomarker validation, experimental design, troubleshooting, and method development.

• Cultivate a robust network of specialty biomarker vendors, enabling you to identify top-tier CROs for collaborative work and guarantee that all vendors adhere to rigorous quality standards and certifications.

• Lead the charge in negotiating contracts, preparing statements of work, and overseeing contract execution with scientific/clinical leads, procurement, contracting, and compliance teams.

• Foster strong relationships with CROs to guarantee the timely processing of biomarker samples, accurate testing, and meticulous data reporting that aligns with development timelines.

• Collaborate closely with data management experts to establish robust data collection, reconciliation, and transfer specifications with CROs.

• Contribute significantly to the preparation of essential clinical documents, including lab report templates, lab manuals, informed consent forms, eCRFs, sample/data management plans, early development plans, and site training materials.

• Take charge of overseeing the collection, handling, storage, and shipment of clinical trial samples to external laboratories, guaranteeing that all processes meet the highest standards of quality and compliance.

• Uphold stringent adherence to ICH/GCP guidelines, best practices in sample storage and management, and ethical standards, ensuring that all activities are conducted with the utmost integrity and professionalism.

• Manage and maintain budgets related to assay development/validation, in-study sample testing, and long-term sample storage, demonstrating your keen financial acumen and dedication to prudent resource management.

Requirements:

• BS/BA degree in Biology, Chemistry, or related science field and 8+ years of relevant experience OR

• Master's in Biology, Chemistry, or related science field and 6+ years of related experience OR

• PharmD or PhD and 4+ years of related experience

• Consistent ability to meet multiple deadlines, with a high degree of accuracy and efficiency

• Advanced project management skills (PMP certification a plus)

• Excellent written, presentation, and verbal communication skills

• Working knowledge of FDA guidance on biomarker method validation and related regulatory aspects.

• Established scientific background on clinical biomarkers and commonly used methodologies

• Experience with clinical study operations teams and understanding of clinical drug development strategic planning of clinical research

• Extensive experience working with CROs to support clinical assay development and sample testing

• Experience with regulatory filings and interactions.

• Experience in GLP, GMP and/or GCP regulated environments and studies

• Proactive, innovative, with exceptional problem-solving and analytical skills

• Ability to lead and/or work as part of a team; typically leads and trains junior scientists and/or other team members

#LI-KM1

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 don't line up to exactly what we have outlined in the job description.

_