Senior Specialist, Clinical Supply Chain (IRT/RTSM)

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:Support Clinical Supply Chain activities, including but not limited to collaborating with internal stakeholders across Project Management, Clinical Operations, Quality Assurance, Regulatory Affairs, Technical Operations (Manufacturing and Analytical), Finance, and Legal, as well as external cGMP service providers.
Key responsibilities include serving as the Clinical Supply Chain subject matter expert (SME) for the configuration and management of Interactive Response Technology (IRT) systems; providing guidance to internal and external users on IRT systems and procedures; troubleshooting system and operational issues; managing system enhancements; and developing procedures and policies as needed.
The ideal candidate must have strong experience working with IRT providers and configuring IRT systems. The successful candidate will demonstrate strong organizational and project management skills, a thorough understanding of clinical study protocols, exceptional attention to detail, and an analytical, problem-solving mindset.
Additional responsibilities include supporting broader Clinical Supply Chain activities, such as managing budgets, contracts, and invoices; coordinating clinical and stability drug packaging and distribution; and managing overall clinical supply logistics. The role will also collaborate with external vendors involved in the planning, packaging, distribution, storage, and destruction of Clinical Trial Materials (CTM).

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

• Support establishment, management and maintenance of IRTs

• Serve as Clinical Supply Chain IRT SME in development and post system go-live

• Participate in development meetings with IRT vendor and Clinical Study Team

• Troubleshoot issues within IRT systems, addressing inquiries, investigating root causes and implementing appropriate solutions or escalation

• Issue RFQs, set up and manage contracts, budgets and billing with qualified IRT Vendors

• Support clinical studies in the planning and execution of drug product management activities

• Support development and review of Clinical Trial Materials (CTM) forecasts based on clinical trial study protocols

• Support packaging/labeling of CTM with approved cGMP vendors, based on approved demands, working with internal partners and systems, processing all drug dispositioning

• Support maintenance of CTM inventory working with vendors to ensure accuracy of inventory systems

• Other duties as assigned

Requirements:

• Bachelor's degree supply chain, life sciences or related field AND 6+ years relevant experience in clinical supply chain, with a heavy experience working with IRTs, packaging and labeling and distribution

• Demonstrated success working with and managing third-party vendors.

• Strong understanding of cGMP supply chain

• In depth knowledge of IRT System development, implementation and maintenance

• Strong knowledge of clinical study tools (CTMS)

• Broad understanding of packaging/labeling requirements

• Ability to effectively work within a multidisciplinary team and manage multiple vendors

• Understands key clinical supply chain business drivers

• Has strong understanding of IRT processes, procedures and systems used to accomplish the work and recognizes downstream impact on other functional areas

• Proficient with tools and processes that support work conducted by functional area

• Ability to work as part of a team; may train lower levels

• Excellent computer skills, proficient in Microsoft Office programs

• Strong communications, problem-solving, analytical thinking skills

• Detail oriented yet can see broader picture for department

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

• Well-organized, detail-oriented with strong written and verbal communication skills

• Strong project management and interpersonal skills

• Self-starter working with a sense of urgency and acting as a team player

• Adaptability, flexibility, independence and resourcefulness with ability to work with changing timelines and willing to roll-up-sleeves in order to thrive in small company environment

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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 $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.